510(k) clearances for Ldl & Vldl Precipitation, Hdl
66 on file
- Roche Diagnostics Operations (Rdo)Jan 28, 2015
K143691 · LDLC3 LDL-Cholesterol Gen.3
- General AtomicsJan 22, 2008
K072523 · DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
- Teco DiagnosticsJul 26, 2005
K050823 · DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
- Hemagen Diagnostics, Inc.Dec 24, 2002
K023784 · RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
- Ortho-Clinical Diagnostics, Inc.Aug 30, 2001
K012593 · VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
- Elan DiagnosticsAug 12, 1999
K992029 · ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- Pointe Scientific, Inc.,Aug 5, 1999
K992002 · AUTOHDL CHOLESTEROL REAGENT SET
- Elan Holdings, Inc.Jul 9, 1999
K991789 · ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- Polymer Technology Systems, Inc.May 28, 1999
K990247 · MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
- Ortho-Clinical Diagnostics, Inc.Jan 28, 1999
K984303 · VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
- Diagnostic Chemicals , Ltd.Apr 27, 1998
K980772 · HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
- Diagnostic Chemicals , Ltd.Apr 21, 1998
K980770 · HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
- Boehringer Mannheim Corp.Jan 26, 1998
K974733 · BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
- Roche Diagnostic Systems, Inc.Nov 21, 1997
K973369 · ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
- Genzyme Corp.Jun 18, 1997
K971573 · N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
- Trace America, Inc.Mar 13, 1997
K962723 · TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
- Genzyme Corp.Aug 19, 1996
K962186 · N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
- Schiapparelli Biosystems, Inc.Dec 11, 1995
K954179 · HDL PRECIPITATING REAGENT
- Reference Diagnostics, Inc.Aug 2, 1995
K944975 · MAGNETIC HDL CHOLESTEROL TEST
- Merchant House ScientificSep 6, 1994
K941744 · PBI PLUS HDL PRECIPITATING REAGENT
- Diagnostic Chemicals, Ltd. (Usa)Dec 10, 1993
K932766 · HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
- Merchant House ScientificDec 9, 1993
K934961 · SPINPRO HDL PRECIPITATING REAGENT
- Merchant House ScientificDec 7, 1993
K934801 · SPINPRO HDL PRECIPITATING REAGENT
- Intersect Systems, Inc.Nov 16, 1993
K934039 · INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
- King Diagnostics, Inc.Aug 16, 1993
K931773 · HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
- Synermed, Inc.Nov 9, 1992
K924427 · SYNERMED HDL CHOLESTLEROL REAGENT KIT
- Instrumentation Laboratory COJan 9, 1992
K914811 · IL TEST(TM) HDL CHOLESTEROL
- Creative Laboratory Products, Inc.Aug 16, 1991
K912823 · HIGH DENSITY LIPOPROTEIN CHOLESTEROL
- Reference Diagnostics, Inc.Jul 18, 1991
K911906 · MAGNETIC HDL CHOLESTEROL TEST
- Genzyme Corp.May 22, 1991
K911406 · HDL CHOLESTEROL REAGENT
- Institute For Clinical ApplicationsJan 15, 1991
K903733 · ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
- Amresco, Inc.Dec 11, 1990
K905284 · HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
- Biotron U.S.A., Inc.Nov 28, 1990
K904184 · BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT
- Diagnostic Resources, Inc.Aug 29, 1990
K903094 · STAT TEST HDL/CHOLESTEROL TEST KIT
- Boehringer Mannheim Corp.Aug 9, 1990
K902568 · REFLOTRON HDL CHOLESTEROL TEST TABS
- Coulter Corp.Jul 31, 1990
K902174 · COULTER HDL - CHOLESTEROL REAGENT
- Roche Diagnostic Systems, Inc.Mar 9, 1990
K900120 · ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
- Trace America, Inc.Nov 8, 1989
K895381 · HDL SINGLES
- Diagnostic SystemsJul 25, 1989
K893966 · HDL PRECIPITATING REAGENT
- Pointe Scientific, Inc.,Apr 10, 1989
K891117 · HDL CHOLESTEROL REAGENT
- Norfolk Scientific, Inc.Mar 8, 1989
K890669 · STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE
- Sigma Diagnostics, Inc.Feb 17, 1989
K890023 · HDL CHOLESTEROL REAGENT (PTA/MGCL2)
- Em Diagnostic Systems, Inc.Feb 10, 1989
K885265 · HDL CHOLESTEROL TEST
- Bd Becton Dickinson Vacutainer Systems PreanalyticSep 13, 1988
K883353 · IQ HDL CHOLESTEROL
- Canyon Diagnostics, Inc.Aug 15, 1988
K882488 · CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
- Trace Scientific , Ltd.Jun 10, 1988
K881244 · HDL CHOLESTEROL KIT
- Data Medical Associates, Inc.May 27, 1988
K881326 · HDL CHOLESTEROL PRECIPITATING PROCEDURE
- Tech-Co, Inc.Feb 18, 1988
K880176 · HDL CHOLESTEROL PRECIPITATING REAGENT
- Simmler, Inc.Jan 7, 1988
K874820 · MULTICHEM HDL PRECIPITATING REAGENT #S0914
- Cooper Biomedical, Inc.Jun 27, 1986
K861926 · WORTHINGTON HDL PRECIPITATING REAGENT SET
- American Monitor Corp.Jul 8, 1985
K852350 · HDL CHOLESTEROL PRETREATMENT
- Livonia Diagnostics, Inc.Nov 2, 1984
K843894 · HDL PRECIPATATING REAGENT SET
- American Monitor Corp.Feb 13, 1984
K834251 · HDL CHOLESTEROL PRETREATMENT
- Preventive Diagnostics Corp.Feb 9, 1984
K833160 · HDL EZ-TAB
- Preventive Diagnostics Corp.Jan 13, 1984
K833431 · HDL EX-SEP PRECIPITATING REAGENT
- Reagents Applications, Inc.Mar 21, 1983
K830207 · RAICHEM HDL-CHOLESTEROL REAGENT
- Omega Medical ElectronicsJul 13, 1982
K821203 · HDL PRECIPITANT REAGENT SET
- Anco Medical Reagents & Assoc.Dec 3, 1981
K812839 · HDL CHOLESTEROL REAGENT SET
- Pointe Scientific, Inc.,Sep 24, 1981
K812574 · HDL CHOLESTEROL REAGENT
- Gilford DiagnosticsMay 14, 1980
K800996 · HDL REAGENT
- Sclavo, Inc.Dec 7, 1979
K792313 · CHOL-HDL TEST, HIGH LIPO. CHOL TEST
- Sherwood Medical Co.Jun 28, 1979
K790865 · LANCER HDL SEPARATION KIT
- General DiagnosticsMay 3, 1979
K790372 · H-D-EL
- Abbott LaboratoriesApr 4, 1979
K790329 · A-GENT-HDL REAGENT
- Beckman Instruments, Inc.Aug 14, 1978
K781093 · HDL CENTRIFIKIT
- Panmed, Inc.May 19, 1978
K780542 · ALFATEST