CDD · Class II · 21 CFR 862.1810

FDA Product Code CDD: Radioassay, Vitamin B12

Leading manufacturers include Axis-Shield Diagnostics, Ltd., Diagnostic Products Corp. and Abbott Laboratories.

78
Total
78
Cleared
98d
Avg days
1976
Since
78 devices
25–48 of 78
Cleared Jan 24, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
K013899
Ortho-Clinical Diagnostics
Toxicology · 62d
Cleared Dec 16, 1999
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
K993571
Bayer Corp.
Chemistry · 56d
Cleared Jan 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
K984321
Ortho-Clinical Diagnostics, Inc.
Immunology · 50d
Cleared Nov 13, 1997
ELECSYS VITAMIN B12 ASSAY
K973702
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Nov 12, 1997
ELECSYS FOLATE
K973674
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared May 16, 1997
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
K971177
Diagnostic Products Corp.
Chemistry · 46d
Cleared Mar 24, 1997
AXSYM B12
K965186
Abbott Laboratories
Chemistry · 90d
Cleared Jan 13, 1997
AIA-PACK B12 ASSAY
K964348
Tosoh Medics, Inc.
Chemistry · 74d
Cleared May 23, 1996
BUHLMANN VITAMIN B6 REA
K955561
American Laboratory Products Co., Ltd.
Chemistry · 169d
Cleared Jan 24, 1996
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
K955436
Bio-Rad Laboratories, Inc.
Chemistry · 114d
Cleared Aug 23, 1995
OPUS B12
K953455
Behring Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 11, 1995
CEDIA VITAMIN B12 (NO BOIL) ASSAY
K951134
Microgenics Corp.
Chemistry · 120d
Cleared Aug 15, 1994
VISTA B12 ASSAY
K941235
Syva Co.
Chemistry · 153d
Cleared Nov 05, 1993
ACCESS VITAMIN B12 ASSAY
K933142
Bio-Rad Laboratories, Inc.
Chemistry · 130d
Cleared Aug 25, 1993
RADIAS B12 ENZYME IMMUNOASSAY
K933315
Bio-Rad
Chemistry · 49d
Cleared Oct 26, 1992
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
K924074
Baxter Diagnostics, Inc.
Chemistry · 75d
Cleared Feb 14, 1992
AFFINITY B12
K920078
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 37d
Cleared Oct 25, 1991
CIBA CORNING ACS T3 IMMUNOASSAY
K913646
Ciba Corning Diagnostics Corp.
Chemistry · 70d
Cleared Mar 06, 1991
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
K910343
Ciba Corning Diagnostics Corp.
Chemistry · 36d
Cleared Nov 20, 1990
CEDIA (R) VITAMIN B12/FOLATE ASSAY
K904776
Microgenics Corp.
Chemistry · 29d
Cleared Nov 04, 1988
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
K883722
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Jul 11, 1986
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
K860815
Diagnostic Products Corp.
Chemistry · 129d
Cleared Feb 11, 1986
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
K854945
Ciba Corning Diagnostics Corp.
Hematology · 63d
Cleared Sep 16, 1985
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
K853127
Micromedic Systems
Chemistry · 53d