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
49–64 of 64
Cleared Jan 16, 1981
'NO-BOIL' DUALCOUNT KIT
K810001
Diagnostic Products Corp.
Chemistry · 10d
Cleared Dec 22, 1980
FOLATE 125I RADIOIMMUNOASSAY
K803060
Corning Medical & Scientific
Chemistry · 101d
Cleared Jul 21, 1980
FOLATE RADIOASSAY KIT
K801198
Calbiochem-Behring Corp.
Chemistry · 63d
Cleared Nov 13, 1979
125 I FOLATE SOLID PHASE RADIOASSAY
K792167
Abbott Laboratories
Chemistry · 18d
Cleared Jul 17, 1979
GAMMADAB (125 1) FOLATE RADIOASSAY KIT
K791079
Clinical Assays, Inc.
Chemistry · 35d
Cleared May 18, 1978
FOLATE REAGENT KIT, ARIA-II SYSTEM
K780557
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 43d
Cleared May 03, 1978
QUANTITOPE 125I-FOLATE RADIOASSAY KIT
K780508
Kallestad Laboratories, Inc.
Chemistry · 34d
Cleared Sep 13, 1977
IN VITRO FOLATE RADIOASSAY KIT
K771597
Clinical Assays, Inc.
Chemistry · 25d
Cleared Jul 26, 1976
KIT, FOLATE RADIOASSAY SC.7
K760207
Amersham Corp.
Chemistry · 17d
Cleared Jul 20, 1976
PROCEDURE, RED CELL FOLATE ASSAY
K760133
Bio-Rad
Chemistry · 22d