CDD · Class II · 21 CFR 862.1810

FDA Product Code CDD: Radioassay, Vitamin B12

Leading manufacturers include Diagnostic Products Corp., Abbott Laboratories and Beckman Coulter, Inc..

78
Total
78
Cleared
98d
Avg days
1976
Since
78 devices
25–48 of 78
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 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
Cleared Jun 25, 1984
VITAMIN B12 57CO/FOLATE 125I -
K840462
Corning Medical & Scientific
Chemistry · 144d
Cleared Jan 30, 1984
ANTIBODY TO INTRINSIC FACTOR RADIOASSAY
K833142
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 138d
Cleared Oct 19, 1983
QUANTAPHASE B-12-COBALMIN-FOLATE-
K833247
Bio-Rad
Chemistry · 19d
Cleared Sep 29, 1983
INTRINSIC FACTOR BLOCKING ANTIBODY KIT
K832726
Diagnostic Products Corp.
Immunology · 48d
Cleared Mar 10, 1983
NO-BOIL SOLID PHASE SIMUL TRAC B12
K822721
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 184d
Cleared Feb 18, 1983
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
K830195
Diagnostic Products Corp.
Chemistry · 29d
Cleared Mar 05, 1982
NO-BOIL VITABIN B12 5760 FOLATE 125I
K813183
Corning Medical & Scientific
Chemistry · 109d