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 Nov 30, 2005
ONE STEP FSH MENOPAUSAL TEST
K052662
Ind Diagnostic, Inc.
Chemistry · 64d
Cleared Feb 25, 2005
MOMENTS MENOPAUSE CHECK, MODEL 9113
K043599
Phamatech, Inc.
Chemistry · 58d
Cleared Jun 17, 2004
FSH MENOPAUSE PREDICTOR TEST
K041165
ACON Laboratories, Inc.
Chemistry · 44d
Cleared Sep 02, 1997
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
K972720
Monobind
Chemistry · 43d
Cleared Feb 14, 1997
SEALITE SCIENCES AQUALITE FSH
K970085
Sealite Sciences, Inc.
Chemistry · 35d
Cleared Feb 04, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
K964720
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 71d
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 Jul 03, 1995
AMERLITE FSH ASSAY
K952285
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 48d
Cleared Jul 20, 1994
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE
K941221
Dupont Medical Products
Chemistry · 128d
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

About Product Code CGJ - Regulatory Context