CGJ · Class I · 21 CFR 862.1300

FDA Product Code CGJ: Radioimmunoassay, Follicle-stimulating Hormone

Leading manufacturers include Medix Biotech, Inc., Amersham Corp. and Abbott Laboratories.

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 Jun 17, 2004
FSH MENOPAUSE PREDICTOR TEST
K041165
ACON Laboratories, Inc.
Chemistry · 44d
Cleared Dec 16, 1996
ELECSYS FSH ASSAY
K964693
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Sep 09, 1996
DSL ACTIVE FSH IRMA
K962118
Diagnostic Systems Laboratories, Inc.
Chemistry · 101d
Cleared Jun 21, 1994
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612
Abbott Laboratories
Chemistry · 211d
Cleared Mar 03, 1994
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
K940005
Bio-Rad Laboratories, Inc.
Chemistry · 59d
Cleared Sep 21, 1993
COBAS CORE FSH EIA
K930304
Roche Diagnostic Systems, Inc.
Chemistry · 243d
Cleared Jun 16, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921746
Biomerieux Vitek, Inc.
Chemistry · 64d
Cleared Dec 18, 1991
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
K915208
Medix Biotech, Inc.
Chemistry · 30d
Cleared Apr 16, 1991
OPUS FSH
K911409
Pb Diagnostic Systems, Inc.
Toxicology · 15d
Cleared Dec 27, 1990
AFFINITY FSH TEST SYSTEM
K905592
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 14d
Cleared Nov 20, 1990
CIBA CORNING ACS FSH IMMUNOASSAY
K904649
Ciba Corning Diagnostics Corp.
Chemistry · 40d
Cleared May 10, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050
K901345
Medix Biotech, Inc.
Chemistry · 49d
Cleared Mar 15, 1990
ENZYMUN TEST(R) FSH
K900763
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Jan 02, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT
K896640
Medix Biotech, Inc.
Chemistry · 39d
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 Sep 13, 1989
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
K894761
Hybritech, Inc.
Chemistry · 48d
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 Dec 06, 1988
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687
Ciba Corning Diagnostics Corp.
Chemistry · 28d
Cleared Nov 30, 1988
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745
Diagnostic Products Corp.
Chemistry · 90d
Cleared Sep 09, 1988
PHASE II FSH KIT
K883279
Vitek Systems, Inc.
Chemistry · 37d
Cleared Jul 21, 1988
AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST
K881142
Amersham Corp.
Chemistry · 126d
Cleared May 27, 1988
FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057
K881596
Medix Biotech, Inc.
Chemistry · 45d

About Product Code CGJ - Regulatory Context