510(k) clearances for Radioassay, Vitamin B12
78 on file
- Axis-Shield Diagnostics, Ltd.Jul 31, 2024
K233541 · ARCHITECT Active-B12 (Holotranscobalamin)
- Beckman Coulter, Inc.Dec 23, 2022
K223289 · Access Vitamin B12
- Beckman Coulter Biomedical GmbHOct 4, 2019
K190298 · DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
- DiaSorin, Inc.Oct 2, 2019
K192064 · LIAISON Vitamin B12
- Axis-Shield Diagnostics, Ltd.Oct 27, 2017
K172133 · ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
- Diazyme LaboratoriesSep 20, 2016
K161721 · Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
- Axis-Shield Diagnostics LimitedJul 26, 2016
K160757 · ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
- Roche DiagnosticsSep 24, 2015
K151786 · Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
- Beckman Coulter, Inc.Sep 16, 2014
K140496 · Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
- Siemens Healthcare DiagnosticsJan 2, 2014
K133512 · LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
- Axis-Shield Diagnostics, Ltd.Mar 22, 2013
K121946 · AXIS-SHIELD ACVTIVE-B12
- Siemens Healthcare Diagnostics, Inc.Nov 30, 2012
K121994 · DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
- Anticancer, Inc.Jul 26, 2012
K111260 · A/C ENZYMATIC VITAMIN B6 ASSAY
- Abbott LaboratoriesMay 17, 2012
K121314 · ARCHITECT B12
- Axis-Shield Diagnostics, Ltd.Dec 19, 2011
K112443 · ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
- Abbott LaboratoriesOct 6, 2011
K110579 · ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
- Beckman Coulter, Inc.May 11, 2011
K110413 · POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
- Siemens Healthcare DiagnosticsFeb 12, 2010
K093631 · B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
- Beckman Coulter, Inc.May 27, 2009
K090588 · POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
- Dade Behring, Inc.Nov 13, 2007
K071224 · DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
- Axis-Shield Diagnostics, Ltd.Nov 22, 2006
K062467 · AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
- Diagnostic Products CorporationApr 28, 2006
K060929 · IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
- Roche Diagnostics Corp.Apr 10, 2006
K060755 · ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
- Abbott LaboratoriesAug 3, 2005
K051327 · ABBOTT AXSYM B12
- Bayer Healthcare, LLCJul 2, 2004
K041133 · MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
- Axis-Shield Biochemicals, AsaJan 29, 2004
K030655 · HOLOTC RIA
- Ortho-Clinical DiagnosticsJan 24, 2002
K013899 · VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
- Bayer Corp.Dec 16, 1999
K993571 · BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
- Ortho-Clinical Diagnostics, Inc.Jan 22, 1999
K984321 · VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
- Boehringer Mannheim Corp.Nov 13, 1997
K973702 · ELECSYS VITAMIN B12 ASSAY
- Boehringer Mannheim Corp.Nov 12, 1997
K973674 · ELECSYS FOLATE
- Diagnostic Products Corp.May 16, 1997
K971177 · IMMULITE VITAMIN B12 (LKVB1,LKVB5)
- Abbott LaboratoriesMar 24, 1997
K965186 · AXSYM B12
- Tosoh Medics, Inc.Jan 13, 1997
K964348 · AIA-PACK B12 ASSAY
- American Laboratory Products Co., Ltd.May 23, 1996
K955561 · BUHLMANN VITAMIN B6 REA
- Bio-Rad Laboratories, Inc.Jan 24, 1996
K955436 · ACCESS VITAMIN B12 ASSAY (MODIFICATION)
- Behring Diagnostics, Inc.Aug 23, 1995
K953455 · OPUS B12
- Microgenics Corp.Jul 11, 1995
K951134 · CEDIA VITAMIN B12 (NO BOIL) ASSAY
- Syva Co.Aug 15, 1994
K941235 · VISTA B12 ASSAY
- Bio-Rad Laboratories, Inc.Nov 5, 1993
K933142 · ACCESS VITAMIN B12 ASSAY
- Bio-RadAug 25, 1993
K933315 · RADIAS B12 ENZYME IMMUNOASSAY
- Baxter Diagnostics, Inc.Oct 26, 1992
K924074 · STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
- Bd Becton Dickinson Vacutainer Systems PreanalyticFeb 14, 1992
K920078 · AFFINITY B12
- Ciba Corning Diagnostics Corp.Oct 25, 1991
K913646 · CIBA CORNING ACS T3 IMMUNOASSAY
- Ciba Corning Diagnostics Corp.Mar 6, 1991
K910343 · CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
- Microgenics Corp.Nov 20, 1990
K904776 · CEDIA (R) VITAMIN B12/FOLATE ASSAY
- Ciba Corning Diagnostics Corp.Nov 4, 1988
K883722 · CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
- Diagnostic Products Corp.Jul 11, 1986
K860815 · SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
- Ciba Corning Diagnostics Corp.Feb 11, 1986
K854945 · MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
- Medical & Scientific Designs, Inc.Oct 3, 1985
K853224 · PHASE II B-12/FOLATE KIT
- Micromedic SystemsSep 16, 1985
K853127 · MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
- Diagnon Corp.Aug 21, 1985
K851377 · DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
- Corning Medical & ScientificJun 25, 1984
K840462 · VITAMIN B12 57CO/FOLATE 125I -
- Bd Becton Dickinson Vacutainer Systems PreanalyticJan 30, 1984
K833142 · ANTIBODY TO INTRINSIC FACTOR RADIOASSAY
- Diagnon Corp.Dec 8, 1983
K832717 · DIAGNON B12 57CO RIA KIT
- Bio-RadOct 19, 1983
K833247 · QUANTAPHASE B-12-COBALMIN-FOLATE-
- Clinical Assays, Inc.Oct 4, 1983
K832711 · VITAMIN B12 FOLATE CA-1515-125
- Clinical Assays, Inc.Oct 4, 1983
K832710 · VITAMIN B12 RADIOASSAY KIT CA-1534
- Diagnostic Products Corp.Sep 29, 1983
K832726 · INTRINSIC FACTOR BLOCKING ANTIBODY KIT
- Bd Becton Dickinson Vacutainer Systems PreanalyticMar 10, 1983
K822721 · NO-BOIL SOLID PHASE SIMUL TRAC B12
- Diagnostic Products Corp.Feb 18, 1983
K830195 · NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
- Corning Medical & ScientificMar 5, 1982
K813183 · NO-BOIL VITABIN B12 5760 FOLATE 125I
- Ria Products, Inc.Dec 17, 1981
K813310 · NO-HOIL COMBOSTAT II KIT
- Diagnostic Products Corp.Jan 16, 1981
K810002 · 'NO-BOIL' VITAMIN B12 KIT
- Corning Medical & ScientificJan 9, 1981
K802220 · VITAMIN B12 (57CO) RADIOIMMUNOASSAY
- Ria Products, Inc.Oct 23, 1980
K801578 · COMBOSTAT - NO-BOIL KIT
- Ria Products, Inc.Oct 23, 1980
K801579 · VITAMIN B12 - NO-BOIL KIT
- Calbiochem-Behring Corp.Feb 13, 1980
K792460 · CALBIOCHEM-BEHRING RIA-COUNT
- New England NuclearNov 13, 1979
K792175 · RIANEN, VITAMIN B12 ASSAY SYSTEM
- Ventrex Laboratories, Inc.Nov 13, 1979
K791216 · CENTRIA VITAMIN B12 FOLATE RADIO SET
- Micromedic SystemsSep 27, 1979
K790347 · AUTO PAK VITAMIN B-12
- Technia Diagnostics , Ltd.Feb 28, 1979
K782024 · RIA KIT, VITAMIN B12
- Ames Div., Miles Laboratories, Inc.Sep 27, 1978
K781410 · RIALYZE VITAMIN B-12 TEST
- Amersham Corp.Jun 13, 1978
K780799 · VITAMIN B12 RADIOASSAY
- Bio-RadJun 27, 1977
K771047 · QUANTA-MATE VITAMIN B-12/FOLATE RA
- Kallestad Laboratories, Inc.Mar 21, 1977
K761321 · VITAMIN B12 RADIOASSAY
- Schwarz MannDec 21, 1976
K760946 · B12/FOLATE SING. TUBE DUAL RADIOASSAY KT
- New England NuclearDec 6, 1976
K760619 · RADIO IMMUNO ASSAY KIT/