CGJ · Radioimmunoassay, Follicle-Stimulating Hormone
Clinical Chemistry · 21 CFR 862.1300 · Class 1
Overview
| Product Code | CGJ |
|---|---|
| Device Name | Radioimmunoassay, Follicle-Stimulating Hormone |
| Regulation | 21 CFR 862.1300 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (88)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052662 | ONE STEP FSH MENOPAUSAL TEST | Ind Diagnostic, Inc. | Nov 30, 2005 | SESE |
| K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 | Phamatech, Inc. | Feb 25, 2005 | SESE |
| K041165 | FSH MENOPAUSE PREDICTOR TEST | ACON Laboratories, Inc. | Jun 17, 2004 | SESE |
| K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | Phamatech, Inc. | May 20, 2004 | SESE |
| K030058 | EARLYDETECT MENOPAUSE TEST FOR FSH | Early Detect, Inc. | Jul 30, 2003 | SESE |
| K002450 | GENUA MENOPAUSE MONITOR TEST KIT | Genua 1944, Inc. | Jan 12, 2001 | SESE |
| K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | Monobind | Sep 2, 1997 | SESE |
| K970085 | SEALITE SCIENCES AQUALITE FSH | Sealite Sciences, Inc. | Feb 14, 1997 | SESE |
| K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) | Johnson & Johnson Clinical Diagnostics, Inc. | Feb 4, 1997 | SESE |
| K964693 | ELECSYS FSH ASSAY | Boehringer Mannheim Corp. | Dec 16, 1996 | SESE |
| K962118 | DSL ACTIVE FSH IRMA | Diagnostic Systems Laboratories, Inc. | Sep 9, 1996 | SESE |
| K952285 | AMERLITE FSH ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | Jul 3, 1995 | SESE |
| K943437 | AQUALITE FSH | Sealite Sciences, Inc. | Dec 28, 1994 | SESE |
| K941221 | DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE | Dupont Medical Products | Jul 20, 1994 | SESE |
| K935612 | AXSYM FOLLICLE STIMULATING HORMONE (FSH) | Abbott Laboratories | Jun 21, 1994 | SESE |
| K940005 | ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY | Bio-Rad Laboratories, Inc. | Mar 3, 1994 | SESE |
| K930304 | COBAS CORE FSH EIA | Roche Diagnostic Systems, Inc. | Sep 21, 1993 | SESE |
| K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | Icn Biomedicals, Inc. | Oct 5, 1992 | SESE |
| K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | Jun 16, 1992 | SESE |
| K921704 | IMMULITE(R) FSH | Cirrus Diagnostics, Inc. | Jun 9, 1992 | SESE |
| K920917 | ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY | Bio Clinic Co. | Mar 26, 1992 | SESE |
| K915208 | FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 | Medix Biotech, Inc. | Dec 18, 1991 | SESE |
| K912804 | FSH IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | Aug 12, 1991 | SESE |
| K911409 | OPUS FSH | Pb Diagnostic Systems, Inc. | Apr 16, 1991 | SESE |
| K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY | London Diagnostics, Inc. | Feb 4, 1991 | SESE |
| K905592 | AFFINITY FSH TEST SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 27, 1990 | SESE |
| K904649 | CIBA CORNING ACS FSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Nov 20, 1990 | SESE |
| K904405 | BIOCLONES ELEGANCE FSH ELISA KIT | Bioclone Australia Pty , Ltd. | Oct 26, 1990 | SESE |
| K901345 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 | Medix Biotech, Inc. | May 10, 1990 | SESE |
| K900763 | ENZYMUN TEST(R) FSH | Boehringer Mannheim Corp. | Mar 15, 1990 | SESE |
| K896864 | FOLLICLE STIMULATING HORMONE-EIA-XT | In Vitro Diagnostics, Inc. | Jan 11, 1990 | SESE |
| K896640 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | Jan 2, 1990 | SESE |
| K895005 | MILENIA(TM) FSH (MKFS1,5) | Diagnostic Products Corp. | Oct 31, 1989 | SESE |
| K895108 | FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 23, 1989 | SESE |
| K894761 | TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | Sep 13, 1989 | SESE |
| K893976 | COAT-A-COUNT (TM) FSH IRMA | Diagnostic Products Corp. | Aug 17, 1989 | SESE |
| K892706 | SR1 (FSH) IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | Jun 9, 1989 | SESE |
| K890135 | IMX FOLLICLE STIMULATING HORMONE (FSH) | Abbott Laboratories | Feb 10, 1989 | SESE |
| K884708 | FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | Jan 17, 1989 | SESE |
| K884687 | CIBA CORNING MAGIC LITE FSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Dec 6, 1988 | SESE |
| K883745 | IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES | Diagnostic Products Corp. | Nov 30, 1988 | SESE |
| K883305 | BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY | Binax, Inc. | Oct 6, 1988 | SESE |
| K883279 | PHASE II FSH KIT | Vitek Systems, Inc. | Sep 9, 1988 | SESE |
| K881142 | AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST | Amersham Corp. | Jul 21, 1988 | SESE |
| K881596 | FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 | Medix Biotech, Inc. | May 27, 1988 | SESE |
| K881123 | ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. | Nichols Institute Diagnostics | Apr 28, 1988 | SESE |
| K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | Oct 20, 1987 | SESE |
| K872309 | MICROMEDIC COMBOSTAT LH/FSH KIT | Micromedic Systems | Jul 31, 1987 | SESE |
| K872627 | FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH | Serono Diagnostics, Inc. | Jul 21, 1987 | SESE |
| K871317 | FOLLICLE STIMULATING HORMONE (HFSH) | Immuchem Corp. | May 20, 1987 | SESE |
| K870520 | TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | Mar 10, 1987 | SESE |
| K863928 | TERUMO SENSIBEAD EIA FSH KIT | Terumo Medical Corp. | Dec 4, 1986 | SESE |
| K864080 | UBI MAGIWEL(TM) FSH QUANTITATIVE | United Biotech, Inc. | Nov 13, 1986 | SESE |
| K863678 | FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | Oct 16, 1986 | SESE |
| K862813 | FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT | Serono Diagnostics, Inc. | Sep 16, 1986 | SESE |
| K862439 | SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA | Boots-Celltech Diagnostics, Inc. | Aug 19, 1986 | SESE |
| K862043 | DELFIA (TM) HFSH KIT | Lkb Instruments, Inc. | Jun 24, 1986 | SESE |
| K854837 | LEE-BEAD BETA FSH (EIA) | Leeco Diagnostics, Inc. | Jan 13, 1986 | SESE |
| K854651 | PARAAMAX CHLORIDE DETERMINATION BY ISE | American Dade | Dec 13, 1985 | SESE |
| K851361 | AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM | Amersham Corp. | May 7, 1985 | SESE |
| K844066 | COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH | Clinetics Corp. | Jan 18, 1985 | SESE |
| K843930 | IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I | Euro-Diagnostics BV | Oct 30, 1984 | SESE |
| K842444 | FSH RIA | Syncor Intl. Corp. | Aug 17, 1984 | SESE |
| K840230 | FSH QUIK RIA KIT | Pacific Biotech, Inc. | Mar 23, 1984 | SESE |
| K834038 | RIANEN FOLLICLE STIMULATING HORMONE | New England Nuclear | Jan 30, 1984 | SESE |
| K833852 | FSH RIA | Syncor Intl. Corp. | Jan 13, 1984 | SESE |
| K831742 | QUANTIMUNE HFSH RIA HUMAN FOLLICLE- | Bio-Rad | Jul 18, 1983 | SESE |
| K823379 | 125-I FSH RADIOIMMUNOASSAY KIT | Clinetics Corp. | Dec 22, 1982 | SESE |
| K822227 | IMMO PHASE FSH RADIOIMMUNOASSAY | Corning Medical & Scientific | Aug 16, 1982 | SESE |
| K821611 | GAMMADAB [125] FSH RADIOIMMUNAY KIT | Clinical Assays, Inc. | Jun 24, 1982 | SESE |
| K820754 | AMERLEX ESH KIT | Amersham Corp. | Apr 15, 1982 | SESE |
| K820740 | MR1 FOLLITROPIN RIA KIT | Microanalytic Research, Inc. | Apr 6, 1982 | SESE |
| K820358 | FOLLICLE STIMULATING HORMONE KIT | Pcl-Ria, Inc. | Mar 26, 1982 | SESE |
| K820048 | FSH RADIOIMMUNOASSAY TEST SYSTEM | Monobind | Feb 4, 1982 | SESE |
| K813086 | ANDRIA-FSH RIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | Dec 17, 1981 | SESE |
| K811993 | RADIOIMMUNOASSAY, FOLLICLE STIMULATING | Endocrine-Metabolic Center | Aug 3, 1981 | SESE |
| K811905 | FOLLICLE STIMULATING HORMONE DIRECT RIA | Immunalysis Corporation | Jul 23, 1981 | SESE |
| K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM | Pcl-Ria, Inc. | Apr 8, 1981 | SESE |
| K810663 | LEECO FSH-QUANT DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | Mar 27, 1981 | SESE |
| K810381 | HTSH RIABEAD DIAGNOSTIC KIT | Abbott Laboratories | Feb 26, 1981 | SESE |
| K803279 | FOLLICE STIMULATING HORMONE-RADIOIMM. KT | Immuno Nuclear Corp. | Jan 16, 1981 | SESE |
| K800107 | FOLLICLE STIMULATING HORMONE | Radioimmunoassay, Inc. | Feb 13, 1980 | SESE |
| K792233 | CENTRIA FSH RIA | Union Carbide Corp. | Jan 21, 1980 | SESE |
| K792063 | FOLLICLE STIMULATING HORMONE (FSH) KIT | Cis Radiopharmaceuticals, Inc. | Nov 20, 1979 | SESE |
| K791836 | QUANTIMUNE HFSH RIA | Bio-Rad | Oct 1, 1979 | SESE |
| K780870 | RIA SYSTEM FOR HUMAN F-S HORMONE | Calbiochem-Behring Corp. | Jun 22, 1978 | SESE |
| K771756 | FOLLICLE-STIMULATING HORMONE | Nichols Institute Diagnostics | Oct 18, 1977 | SESE |
| K760373 | RADIOASSAY KIT, IM.72 FSH | Amersham Corp. | Nov 1, 1976 | SESE |
Top Applicants
- Medix Biotech, Inc. — 4 clearances
- Amersham Corp. — 4 clearances
- Nichols Institute Diagnostics — 3 clearances
- Diagnostic Products Corp. — 3 clearances
- Abbott Laboratories — 3 clearances
