Atlas FDA

CGJ

88 FDA 510(k) clearances · Product code

45 daysmedian time to decision
101 days90th percentile
88clearances measured

FDA profile

Official device name
Radioimmunoassay, Follicle-Stimulating Hormone
Device class
Class I (low risk)
Regulation
21 CFR 862.1300
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2006: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ONE STEP FSH MENOPAUSAL TEST (K052662)Ind Diagnostic, Inc.2005-11-30
MOMENTS MENOPAUSE CHECK, MODEL 9113 (K043599)Phamatech, Inc.2005-02-25
FSH MENOPAUSE PREDICTOR TEST (K041165)ACON Laboratories, Inc.2004-06-17
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (K040575)Phamatech, Inc.2004-05-20
EARLYDETECT MENOPAUSE TEST FOR FSH (K030058)Early Detect, Inc.2003-07-30
GENUA MENOPAUSE MONITOR TEST KIT (K002450)Genua 1944, Inc.2001-01-12
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (K972720)Monobind1997-09-02
SEALITE SCIENCES AQUALITE FSH (K970085)Sealite Sciences, Inc.1997-02-14
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) (K964720)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-04
ELECSYS FSH ASSAY (K964693)Boehringer Mannheim Corp.1996-12-16
DSL ACTIVE FSH IRMA (K962118)Diagnostic Systems Laboratories, Inc.1996-09-09
AMERLITE FSH ASSAY (K952285)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-03
AQUALITE FSH (K943437)Sealite Sciences, Inc.1994-12-28
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE (K941221)Dupont Medical Products1994-07-20
AXSYM FOLLICLE STIMULATING HORMONE (FSH) (K935612)Abbott Laboratories1994-06-21
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY (K940005)Bio-Rad Laboratories, Inc.1994-03-03
COBAS CORE FSH EIA (K930304)Roche Diagnostic Systems, Inc.1993-09-21
ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT (K922376)Icn Biomedicals, Inc.1992-10-05
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921746)Biomerieux Vitek, Inc.1992-06-16
IMMULITE(R) FSH (K921704)Cirrus Diagnostics, Inc.1992-06-09
ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY (K920917)Bio Clinic Co.1992-03-26
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 (K915208)Medix Biotech, Inc.1991-12-18
FSH IRMA IMMUNOMAG (K912804)Pantex, Div. Bio-Analysis, Inc.1991-08-12
OPUS FSH (K911409)Pb Diagnostic Systems, Inc.1991-04-16
LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY (K905814)London Diagnostics, Inc.1991-02-04
AFFINITY FSH TEST SYSTEM (K905592)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-27
CIBA CORNING ACS FSH IMMUNOASSAY (K904649)Ciba Corning Diagnostics Corp.1990-11-20
BIOCLONES ELEGANCE FSH ELISA KIT (K904405)Bioclone Australia Pty , Ltd.1990-10-26
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 (K901345)Medix Biotech, Inc.1990-05-10
ENZYMUN TEST(R) FSH (K900763)Boehringer Mannheim Corp.1990-03-15
FOLLICLE STIMULATING HORMONE-EIA-XT (K896864)In Vitro Diagnostics, Inc.1990-01-11
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT (K896640)Medix Biotech, Inc.1990-01-02
MILENIA(TM) FSH (MKFS1,5) (K895005)Diagnostic Products Corp.1989-10-31
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. (K895108)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-23
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT (K894761)Hybritech, Inc.1989-09-13
COAT-A-COUNT (TM) FSH IRMA (K893976)Diagnostic Products Corp.1989-08-17
SR1 (FSH) IMMUNOENZYMETRIC ASSAY (K892706)Serono-Baker Diagnostics, Inc.1989-06-09
IMX FOLLICLE STIMULATING HORMONE (FSH) (K890135)Abbott Laboratories1989-02-10
FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT (K884708)Cyberfluor, Inc.1989-01-17
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY (K884687)Ciba Corning Diagnostics Corp.1988-12-06
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES (K883745)Diagnostic Products Corp.1988-11-30
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY (K883305)Binax, Inc.1988-10-06
PHASE II FSH KIT (K883279)Vitek Systems, Inc.1988-09-09
AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST (K881142)Amersham Corp.1988-07-21
FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 (K881596)Medix Biotech, Inc.1988-05-27
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. (K881123)Nichols Institute Diagnostics1988-04-28
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY (K873051)American Dade1987-10-20
MICROMEDIC COMBOSTAT LH/FSH KIT (K872309)Micromedic Systems1987-07-31
FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH (K872627)Serono Diagnostics, Inc.1987-07-21
FOLLICLE STIMULATING HORMONE (HFSH) (K871317)Immuchem Corp.1987-05-20
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY (K870520)Hybritech, Inc.1987-03-10
TERUMO SENSIBEAD EIA FSH KIT (K863928)Terumo Medical Corp.1986-12-04
UBI MAGIWEL(TM) FSH QUANTITATIVE (K864080)United Biotech, Inc.1986-11-13
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM (K863678)Nichols Institute Diagnostics1986-10-16
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT (K862813)Serono Diagnostics, Inc.1986-09-16
SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA (K862439)Boots-Celltech Diagnostics, Inc.1986-08-19
DELFIA (TM) HFSH KIT (K862043)Lkb Instruments, Inc.1986-06-24
LEE-BEAD BETA FSH (EIA) (K854837)Leeco Diagnostics, Inc.1986-01-13
PARAAMAX CHLORIDE DETERMINATION BY ISE (K854651)American Dade1985-12-13
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM (K851361)Amersham Corp.1985-05-07
COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH (K844066)Clinetics Corp.1985-01-18
IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I (K843930)Euro-Diagnostics BV1984-10-30
FSH RIA (K842444)Syncor Intl. Corp.1984-08-17
FSH QUIK RIA KIT (K840230)Pacific Biotech, Inc.1984-03-23
RIANEN FOLLICLE STIMULATING HORMONE (K834038)New England Nuclear1984-01-30
FSH RIA (K833852)Syncor Intl. Corp.1984-01-13
QUANTIMUNE HFSH RIA HUMAN FOLLICLE- (K831742)Bio-Rad1983-07-18
125-I FSH RADIOIMMUNOASSAY KIT (K823379)Clinetics Corp.1982-12-22
IMMO PHASE FSH RADIOIMMUNOASSAY (K822227)Corning Medical & Scientific1982-08-16
GAMMADAB [125] FSH RADIOIMMUNAY KIT (K821611)Clinical Assays, Inc.1982-06-24
AMERLEX ESH KIT (K820754)Amersham Corp.1982-04-15
MR1 FOLLITROPIN RIA KIT (K820740)Microanalytic Research, Inc.1982-04-06
FOLLICLE STIMULATING HORMONE KIT (K820358)Pcl-Ria, Inc.1982-03-26
FSH RADIOIMMUNOASSAY TEST SYSTEM (K820048)Monobind1982-02-04
ANDRIA-FSH RIA TEST KIT (K813086)Intl. Immunoassay Laboratories, Inc.1981-12-17
RADIOIMMUNOASSAY, FOLLICLE STIMULATING (K811993)Endocrine-Metabolic Center1981-08-03
FOLLICLE STIMULATING HORMONE DIRECT RIA (K811905)Immunalysis Corporation1981-07-23
FOLLICLE STIMULATING HORMONE ANTISERUM (K810852)Pcl-Ria, Inc.1981-04-08
LEECO FSH-QUANT DIAGNOSTIC KIT (K810663)Leeco Diagnostics, Inc.1981-03-27
HTSH RIABEAD DIAGNOSTIC KIT (K810381)Abbott Laboratories1981-02-26
FOLLICE STIMULATING HORMONE-RADIOIMM. KT (K803279)Immuno Nuclear Corp.1981-01-16
FOLLICLE STIMULATING HORMONE (K800107)Radioimmunoassay, Inc.1980-02-13
CENTRIA FSH RIA (K792233)Union Carbide Corp.1980-01-21
FOLLICLE STIMULATING HORMONE (FSH) KIT (K792063)Cis Radiopharmaceuticals, Inc.1979-11-20
QUANTIMUNE HFSH RIA (K791836)Bio-Rad1979-10-01
RIA SYSTEM FOR HUMAN F-S HORMONE (K780870)Calbiochem-Behring Corp.1978-06-22
FOLLICLE-STIMULATING HORMONE (K771756)Nichols Institute Diagnostics1977-10-18
RADIOASSAY KIT, IM.72 FSH (K760373)Amersham Corp.1976-11-01

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