Apolipoproteins
Clinical Chemistry · 21 CFR 862.1475
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
27 firms currently registered for this product code
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Acro Biotech Inc.
Montclair, CA, US
Diasorin Inc.
Stillwater, MN, US
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Diazyme Laboratories, Inc.
POWAY, CA, US
Ortho Clinical Diagnostics
Singapore South West, SG
Beckman Coulter, Inc.
CARLSBAD, CA, US
Beckman Coulter, Inc.
BREA, CA, US
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Kent Laboratories, Inc.
BELLINGHAM, WA, US
Mercodia Ab
UPPSALA, SE
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Tst Biomedical Electronics Co., Ltd.
Taoyuan, TW
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Cliniqa Corporation
San Marcos, CA, US
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
510(k) clearances
50 clearances for this product code
- General AtomicsJul 16, 2008
K072977 · DIAZYME APOLIPOPROTEIN A-1 ASSAY
- Diazyme LaboratoriesMar 7, 2008
K073488 · DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
- Pointe Scientific, Inc.,Mar 28, 2007
K061377 · APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
- Dade Behring, Inc.Feb 23, 2007
K063608 · DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- Bayer Corp.Feb 15, 2000
K992662 · 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- Beckman Instruments, Inc.Apr 21, 1997
K970314 · SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
- Beckman Instruments, Inc.Feb 10, 1997
K964010 · IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
- Nichols InstituteAug 16, 1993
K931777 · APO A-1 CHEMILUMINESCENCE ASSAY