ClearanceBrief
Panels › Clinical Chemistry › Product code CDD · Class 2

Radioassay, Vitamin B12

Regulation 862.1810

0510(k)s in 12 months (78 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
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Top companies in CDD

Decided510(k)Device and applicantCode
Sep 16, 1985K853127MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
Micromedic Systems
CDD
Aug 21, 1985K851377DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
Diagnon Corp.
CDD
Jun 25, 1984K840462VITAMIN B12 57CO/FOLATE 125I -
Corning Medical & Scientific
CDD
Jan 30, 1984K833142ANTIBODY TO INTRINSIC FACTOR RADIOASSAY
Bd Becton Dickinson Vacutainer Systems Preanalytic
CDD
Dec 8, 1983K832717DIAGNON B12 57CO RIA KIT
Diagnon Corp.
CDD
Oct 19, 1983K833247QUANTAPHASE B-12-COBALMIN-FOLATE-
Bio-Rad
CDD
Oct 4, 1983K832711VITAMIN B12 FOLATE CA-1515-125
Clinical Assays, Inc.
CDD
Oct 4, 1983K832710VITAMIN B12 RADIOASSAY KIT CA-1534
Clinical Assays, Inc.
CDD
Sep 29, 1983K832726INTRINSIC FACTOR BLOCKING ANTIBODY KIT
Diagnostic Products Corp.
CDD
Mar 10, 1983K822721NO-BOIL SOLID PHASE SIMUL TRAC B12
Bd Becton Dickinson Vacutainer Systems Preanalytic
CDD
Feb 18, 1983K830195NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
Diagnostic Products Corp.
CDD
Mar 5, 1982K813183NO-BOIL VITABIN B12 5760 FOLATE 125I
Corning Medical & Scientific
CDD
Dec 17, 1981K813310NO-HOIL COMBOSTAT II KIT
Ria Products, Inc.
CDD
Jan 16, 1981K810002'NO-BOIL' VITAMIN B12 KIT
Diagnostic Products Corp.
CDD
Jan 9, 1981K802220VITAMIN B12 (57CO) RADIOIMMUNOASSAY
Corning Medical & Scientific
CDD
Oct 23, 1980K801579VITAMIN B12 - NO-BOIL KIT
Ria Products, Inc.
CDD
Oct 23, 1980K801578COMBOSTAT - NO-BOIL KIT
Ria Products, Inc.
CDD
Feb 13, 1980K792460CALBIOCHEM-BEHRING RIA-COUNT
Calbiochem-Behring Corp.
CDD
Nov 13, 1979K792175RIANEN, VITAMIN B12 ASSAY SYSTEM
New England Nuclear
CDD
Nov 13, 1979K791216CENTRIA VITAMIN B12 FOLATE RADIO SET
Ventrex Laboratories, Inc.
CDD
Sep 27, 1979K790347AUTO PAK VITAMIN B-12
Micromedic Systems
CDD
Feb 28, 1979K782024RIA KIT, VITAMIN B12
Technia Diagnostics , Ltd.
CDD
Sep 27, 1978K781410RIALYZE VITAMIN B-12 TEST
Ames Div., Miles Laboratories, Inc.
CDD
Jun 13, 1978K780799VITAMIN B12 RADIOASSAY
Amersham Corp.
CDD
Jun 27, 1977K771047QUANTA-MATE VITAMIN B-12/FOLATE RA
Bio-Rad
CDD
Mar 21, 1977K761321VITAMIN B12 RADIOASSAY
Kallestad Laboratories, Inc.
CDD
Dec 21, 1976K760946B12/FOLATE SING. TUBE DUAL RADIOASSAY KT
Schwarz Mann
CDD
Dec 6, 1976K760619RADIO IMMUNO ASSAY KIT/
New England Nuclear
CDD

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