CGN · Class II · 21 CFR 862.1295

FDA Product Code CGN: Acid, Folic, Radioimmunoassay

Leading manufacturers include Abbott Laboratories, Beckman Coulter, Inc. and Bio-Rad.

64
Total
64
Cleared
85d
Avg days
1976
Since
64 devices
25–48 of 64
Cleared Nov 27, 1996
AIA-PACK FOLATE ASSAY
K964349
Tosoh Medics, Inc.
Chemistry · 27d
Cleared Jul 26, 1996
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
K960800
Boehringer Mannheim Corp.
Chemistry · 150d
Cleared Jan 29, 1996
ACCESS FOLATE ASSAY (MODIFICATION)
K955434
Beckman Coulter, Inc.
Chemistry · 119d
Cleared Jan 24, 1996
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K954332
Bayer Corp.
Chemistry · 128d
Cleared Jun 29, 1995
CEDIA FOLATE (NO BOIL) ASSAY
K951155
Microgenics Corp.
Chemistry · 107d
Cleared Feb 03, 1995
RADIAS RED CELL FOLATE IMMUNOASAY
K944212
Bio-Rad
Chemistry · 158d
Cleared Jan 17, 1995
CEDIA(R) FOLATE (NO BOIL) ASSAY
K946184
Microgenics Corp.
Chemistry · 28d
Cleared Dec 12, 1994
CIBA CORNING ACS FOLATE ASSAY
K943297
Ciba Corning Diagnostics Corp.
Chemistry · 157d
Cleared Oct 31, 1994
FOLIC ACID
K943705
Diagnostic Products Corp.
Chemistry · 91d
Cleared Aug 26, 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
K943149
Beckman Coulter, Inc.
Immunology · 57d
Cleared Feb 18, 1994
QUANTAPHASE II B12/FOLATE
K935286
Bio-Rad
Chemistry · 137d
Cleared Oct 22, 1993
VISTA FOLATE ASSAY
K934121
Syva Co.
Chemistry · 58d
Cleared Oct 12, 1993
ACCESS FOLATE ASSAY
K932887
Beckman Coulter, Inc.
Immunology · 120d
Cleared Oct 01, 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
K933571
Bio-Rad
Chemistry · 70d
Cleared Sep 17, 1992
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY
K923286
Baxter Diagnostics, Inc.
Toxicology · 73d
Cleared Aug 05, 1992
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
K922823
Bio-Rad Laboratories, Inc.
Chemistry · 55d
Cleared Jun 25, 1992
MILENIA FOLIC ACID
K921614
Diagnostic Products Corp.
Chemistry · 80d
Cleared Jun 16, 1992
CEDIA RED BLOOD CELL FOLATE REAGENT PACK
K921689
Microgenics Corp.
Chemistry · 69d
Cleared Jul 27, 1989
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY
K893684
Ciba Corning Diagnostics Corp.
Chemistry · 72d
Cleared Oct 04, 1983
FOLATE RADIOASSAY KIT CA-1562-125
K832712
Clinical Assays, Inc.
Chemistry · 53d
Cleared Nov 05, 1982
SOLID PHASE SIMUL TRAC VITAMIN B12
K822728
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 58d
Cleared Nov 24, 1981
VITAMIN B12/FOLATE DUAL RADIOASSAY KITS
K812979
Amersham Corp.
Chemistry · 32d
Cleared May 15, 1981
QUANTA PHASE VITAMIN B-12/FOLATE RAD
K811177
Bio-Rad
Chemistry · 17d
Cleared Feb 04, 1981
MICROMEDIC SYSTEMS' AUTOPAK
K810186
Micromedic Systems
Chemistry · 13d