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
49–72 of 78
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 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