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
88 devices
25–48 of 88
Cleared Aug 17, 1989
COAT-A-COUNT (TM) FSH IRMA
K893976
Diagnostic Products Corp.
Microbiology · 76d
Cleared Jun 09, 1989
SR1 (FSH) IMMUNOENZYMETRIC ASSAY
K892706
Serono-Baker Diagnostics, Inc.
Chemistry · 56d
Cleared Feb 10, 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135
Abbott Laboratories
Chemistry · 28d
Cleared Jan 17, 1989
FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884708
Cyberfluor, Inc.
Chemistry · 69d
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 Oct 06, 1988
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
K883305
Binax, Inc.
Chemistry · 63d
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
Cleared Apr 28, 1988
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
K881123
Nichols Institute Diagnostics
Chemistry · 43d
Cleared Oct 20, 1987
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051
American Dade
Chemistry · 77d
Cleared Jul 31, 1987
MICROMEDIC COMBOSTAT LH/FSH KIT
K872309
Micromedic Systems
Chemistry · 45d
Cleared Jul 21, 1987
FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH
K872627
Serono Diagnostics, Inc.
Chemistry · 15d
Cleared May 20, 1987
FOLLICLE STIMULATING HORMONE (HFSH)
K871317
Immuchem Corp.
Chemistry · 48d
Cleared Mar 10, 1987
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520
Hybritech, Inc.
Chemistry · 32d
Cleared Dec 04, 1986
TERUMO SENSIBEAD EIA FSH KIT
K863928
Terumo Medical Corp.
Chemistry · 57d
Cleared Nov 13, 1986
UBI MAGIWEL(TM) FSH QUANTITATIVE
K864080
United Biotech, Inc.
Chemistry · 24d
Cleared Oct 16, 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
K863678
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Sep 16, 1986
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT
K862813
Serono Diagnostics, Inc.
Chemistry · 54d
Cleared Aug 19, 1986
SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
K862439
Boots-Celltech Diagnostics, Inc.
Chemistry · 54d
Cleared Jun 24, 1986
DELFIA (TM) HFSH KIT
K862043
Lkb Instruments, Inc.
Chemistry · 27d
Cleared Jan 13, 1986
LEE-BEAD BETA FSH (EIA)
K854837
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Dec 13, 1985
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651
American Dade
Chemistry · 24d