CGJ · Class I · 21 CFR 862.1300

FDA Product Code CGJ: Radioimmunoassay, Follicle-stimulating Hormone

Leading manufacturers include Medix Biotech, Inc., Amersham Corp. and Nichols Institute Diagnostics.

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 May 20, 2004
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
K040575
Phamatech, Inc.
Chemistry · 77d
Cleared Jul 30, 2003
EARLYDETECT MENOPAUSE TEST FOR FSH
K030058
Early Detect, Inc.
Chemistry · 204d
Cleared Jan 12, 2001
GENUA MENOPAUSE MONITOR TEST KIT
K002450
Genua 1944, Inc.
Chemistry · 156d
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 Dec 28, 1994
AQUALITE FSH
K943437
Sealite Sciences, Inc.
Chemistry · 163d
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 Oct 05, 1992
ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT
K922376
Icn Biomedicals, Inc.
Chemistry · 138d
Cleared Jun 16, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921746
Biomerieux Vitek, Inc.
Chemistry · 64d
Cleared Jun 09, 1992
IMMULITE(R) FSH
K921704
Cirrus Diagnostics, Inc.
Chemistry · 60d
Cleared Mar 26, 1992
ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY
K920917
Bio Clinic Co.
Chemistry · 27d
Cleared Dec 18, 1991
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
K915208
Medix Biotech, Inc.
Chemistry · 30d
Cleared Aug 12, 1991
FSH IRMA IMMUNOMAG
K912804
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 48d
Cleared Apr 16, 1991
OPUS FSH
K911409
Pb Diagnostic Systems, Inc.
Toxicology · 15d

About Product Code CGJ - Regulatory Context