CGJ · Class I · 21 CFR 862.1300

FDA Product Code CGJ: Radioimmunoassay, Follicle-stimulating Hormone

Leading manufacturers include Abbott Laboratories, Diagnostic Products Corp. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

88
Total
88
Cleared
55d
Avg days
1976
Since

FDA 510(k) Cleared Radioimmunoassay, Follicle-stimulating Hormone Devices (Product Code CGJ)

88 devices
1–24 of 88
Cleared Dec 16, 1996
ELECSYS FSH ASSAY
K964693
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Jun 21, 1994
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612
Abbott Laboratories
Chemistry · 211d
Cleared Sep 21, 1993
COBAS CORE FSH EIA
K930304
Roche Diagnostic Systems, Inc.
Chemistry · 243d
Cleared Dec 27, 1990
AFFINITY FSH TEST SYSTEM
K905592
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 14d
Cleared Mar 15, 1990
ENZYMUN TEST(R) FSH
K900763
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Oct 31, 1989
MILENIA(TM) FSH (MKFS1,5)
K895005
Diagnostic Products Corp.
Chemistry · 84d
Cleared Oct 23, 1989
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.
K895108
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 69d
Cleared Aug 17, 1989
COAT-A-COUNT (TM) FSH IRMA
K893976
Diagnostic Products Corp.
Microbiology · 76d
Cleared Feb 10, 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135
Abbott Laboratories
Chemistry · 28d
Cleared Nov 30, 1988
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745
Diagnostic Products Corp.
Chemistry · 90d
Cleared Jul 18, 1983
QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
K831742
Bio-Rad
Chemistry · 48d
Cleared Feb 26, 1981
HTSH RIABEAD DIAGNOSTIC KIT
K810381
Abbott Laboratories
Chemistry · 13d
Cleared Oct 01, 1979
QUANTIMUNE HFSH RIA
K791836
Bio-Rad
Chemistry · 17d

About Product Code CGJ - Regulatory Context