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 Beckman Coulter, Inc..

78
Total
78
Cleared
98d
Avg days
1976
Since
78 devices
49–72 of 78
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 Oct 04, 1983
VITAMIN B12 RADIOASSAY KIT CA-1534
K832710
Clinical Assays, Inc.
Chemistry · 53d
Cleared Oct 04, 1983
VITAMIN B12 FOLATE CA-1515-125
K832711
Clinical Assays, Inc.
Chemistry · 53d
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
Cleared Jan 16, 1981
'NO-BOIL' VITAMIN B12 KIT
K810002
Diagnostic Products Corp.
Chemistry · 10d
Cleared Jan 09, 1981
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
K802220
Corning Medical & Scientific
Hematology · 119d
Cleared Feb 13, 1980
CALBIOCHEM-BEHRING RIA-COUNT
K792460
Calbiochem-Behring Corp.
Chemistry · 72d
Cleared Nov 13, 1979
CENTRIA VITAMIN B12 FOLATE RADIO SET
K791216
Ventrex Laboratories, Inc.
Chemistry · 134d
Cleared Nov 13, 1979
RIANEN, VITAMIN B12 ASSAY SYSTEM
K792175
New England Nuclear
Chemistry · 15d
Cleared Sep 27, 1979
AUTO PAK VITAMIN B-12
K790347
Micromedic Systems
Chemistry · 218d
Cleared Jun 13, 1978
VITAMIN B12 RADIOASSAY
K780799
Amersham Corp.
Chemistry · 29d
Cleared Jun 27, 1977
QUANTA-MATE VITAMIN B-12/FOLATE RA
K771047
Bio-Rad
Immunology · 17d
Cleared Mar 21, 1977
VITAMIN B12 RADIOASSAY
K761321
Kallestad Laboratories, Inc.
Chemistry · 84d
Cleared Dec 06, 1976
RADIO IMMUNO ASSAY KIT/
K760619
New England Nuclear
Chemistry · 84d