CGJ · Class I · 21 CFR 862.1300

FDA Product Code CGJ: Radioimmunoassay, Follicle-stimulating Hormone

Leading manufacturers include Medix Biotech, Inc., Amersham Corp. and Diagnostic Products Corp..

88
Total
88
Cleared
55d
Avg days
1976
Since
88 devices
25–48 of 88
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 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 Oct 16, 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
K863678
Nichols Institute Diagnostics
Chemistry · 27d
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
Cleared May 07, 1985
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
K851361
Amersham Corp.
Chemistry · 33d
Cleared Jul 18, 1983
QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
K831742
Bio-Rad
Chemistry · 48d
Cleared Aug 16, 1982
IMMO PHASE FSH RADIOIMMUNOASSAY
K822227
Corning Medical & Scientific
Chemistry · 20d
Cleared Apr 15, 1982
AMERLEX ESH KIT
K820754
Amersham Corp.
Chemistry · 27d
Cleared Jul 23, 1981
FOLLICLE STIMULATING HORMONE DIRECT RIA
K811905
Immunalysis Corporation
Chemistry · 22d
Cleared Mar 27, 1981
LEECO FSH-QUANT DIAGNOSTIC KIT
K810663
Leeco Diagnostics, Inc.
Chemistry · 16d
Cleared Feb 26, 1981
HTSH RIABEAD DIAGNOSTIC KIT
K810381
Abbott Laboratories
Chemistry · 13d
Cleared Jan 21, 1980
CENTRIA FSH RIA
K792233
Union Carbide Corp.
Chemistry · 77d
Cleared Oct 01, 1979
QUANTIMUNE HFSH RIA
K791836
Bio-Rad
Chemistry · 17d
Cleared Jun 22, 1978
RIA SYSTEM FOR HUMAN F-S HORMONE
K780870
Calbiochem-Behring Corp.
Chemistry · 23d
Cleared Oct 18, 1977
FOLLICLE-STIMULATING HORMONE
K771756
Nichols Institute Diagnostics
Chemistry · 32d
Cleared Nov 01, 1976
RADIOASSAY KIT, IM.72 FSH
K760373
Amersham Corp.
Immunology · 88d