CDD · Class II · 21 CFR 862.1810

FDA Product Code CDD: Radioassay, Vitamin B12

Leading manufacturers include Diagnostic Products Corp., Axis-Shield Diagnostics, Ltd. and Ciba Corning Diagnostics Corp..

78
Total
78
Cleared
98d
Avg days
1976
Since
78 devices
49–72 of 78
Cleared Feb 11, 1986
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
K854945
Ciba Corning Diagnostics Corp.
Hematology · 63d
Cleared Oct 03, 1985
PHASE II B-12/FOLATE KIT
K853224
Medical & Scientific Designs, Inc.
Chemistry · 63d
Cleared Sep 16, 1985
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
K853127
Micromedic Systems
Chemistry · 53d
Cleared Aug 21, 1985
DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
K851377
Diagnon Corp.
Chemistry · 135d
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 Dec 08, 1983
DIAGNON B12 57CO RIA KIT
K832717
Diagnon Corp.
Chemistry · 118d
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 Dec 17, 1981
NO-HOIL COMBOSTAT II KIT
K813310
Ria Products, Inc.
Chemistry · 23d
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 Feb 28, 1979
RIA KIT, VITAMIN B12
K782024
Technia Diagnostics , Ltd.
Chemistry · 85d
Cleared Sep 27, 1978
RIALYZE VITAMIN B-12 TEST
K781410
Ames Div., Miles Laboratories, Inc.
Chemistry · 44d
Cleared Jun 13, 1978
VITAMIN B12 RADIOASSAY
K780799
Amersham Corp.
Chemistry · 29d