FDA Product Code
FDA Product Code CGJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1300
510(k) Clearances — 88 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K052662 | ONE STEP FSH MENOPAUSAL TEST | Ind Diagnostic, Inc. | 2005-11-30 | Traditional | PDF ↗ |
| K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 | Phamatech, Inc. | 2005-02-25 | Special | PDF ↗ |
| K041165 | FSH MENOPAUSE PREDICTOR TEST | ACON Laboratories, Inc. | 2004-06-17 | Traditional | PDF ↗ |
| K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | Phamatech, Inc. | 2004-05-20 | Traditional | PDF ↗ |
| K030058 | EARLYDETECT MENOPAUSE TEST FOR FSH | Early Detect, Inc. | 2003-07-30 | Traditional | PDF ↗ |
| K002450 | GENUA MENOPAUSE MONITOR TEST KIT | Genua 1944, Inc. | 2001-01-12 | Traditional | PDF ↗ |
| K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | Monobind | 1997-09-02 | Traditional | PDF ↗ |
| K970085 | SEALITE SCIENCES AQUALITE FSH | Sealite Sciences, Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K964693 | ELECSYS FSH ASSAY | Boehringer Mannheim Corp. | 1996-12-16 | Traditional | PDF ↗ |
| K962118 | DSL ACTIVE FSH IRMA | Diagnostic Systems Laboratories, Inc. | 1996-09-09 | Traditional | PDF ↗ |
| K952285 | AMERLITE FSH ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K943437 | AQUALITE FSH | Sealite Sciences, Inc. | 1994-12-28 | Traditional | PDF ↗ |
| K941221 | DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE | Dupont Medical Products | 1994-07-20 | Traditional | PDF ↗ |
| K935612 | AXSYM FOLLICLE STIMULATING HORMONE (FSH) | Abbott Laboratories | 1994-06-21 | Traditional | PDF ↗ |
| K940005 | ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY | Bio-Rad Laboratories, Inc. | 1994-03-03 | Traditional | PDF ↗ |
| K930304 | COBAS CORE FSH EIA | Roche Diagnostic Systems, Inc. | 1993-09-21 | Traditional | PDF ↗ |
| K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | Icn Biomedicals, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | 1992-06-16 | Traditional | PDF ↗ |
| K921704 | IMMULITE(R) FSH | Cirrus Diagnostics, Inc. | 1992-06-09 | Traditional | PDF ↗ |
| K920917 | ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY | Bio Clinic Co. | 1992-03-26 | Traditional | PDF ↗ |
| K915208 | FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 | Medix Biotech, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K912804 | FSH IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K911409 | OPUS FSH | Pb Diagnostic Systems, Inc. | 1991-04-16 | Traditional | PDF ↗ |
| K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY | London Diagnostics, Inc. | 1991-02-04 | Traditional | PDF ↗ |
| K905592 | AFFINITY FSH TEST SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-12-27 | Traditional | PDF ↗ |
| K904649 | CIBA CORNING ACS FSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1990-11-20 | Traditional | PDF ↗ |
| K904405 | BIOCLONES ELEGANCE FSH ELISA KIT | Bioclone Australia Pty , Ltd. | 1990-10-26 | Traditional | PDF ↗ |
| K901345 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 | Medix Biotech, Inc. | 1990-05-10 | Traditional | PDF ↗ |
| K900763 | ENZYMUN TEST(R) FSH | Boehringer Mannheim Corp. | 1990-03-15 | Traditional | PDF ↗ |
| K896864 | FOLLICLE STIMULATING HORMONE-EIA-XT | In Vitro Diagnostics, Inc. | 1990-01-11 | Traditional | PDF ↗ |
| K896640 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1990-01-02 | Traditional | PDF ↗ |
| K895005 | MILENIA(TM) FSH (MKFS1,5) | Diagnostic Products Corp. | 1989-10-31 | Traditional | PDF ↗ |
| K895108 | FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-23 | Traditional | PDF ↗ |
| K894761 | TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | 1989-09-13 | Traditional | PDF ↗ |
| K893976 | COAT-A-COUNT (TM) FSH IRMA | Diagnostic Products Corp. | 1989-08-17 | Traditional | PDF ↗ |
| K892706 | SR1 (FSH) IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-06-09 | Traditional | PDF ↗ |
| K890135 | IMX FOLLICLE STIMULATING HORMONE (FSH) | Abbott Laboratories | 1989-02-10 | Traditional | PDF ↗ |
| K884708 | FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K884687 | CIBA CORNING MAGIC LITE FSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1988-12-06 | Traditional | PDF ↗ |
| K883745 | IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES | Diagnostic Products Corp. | 1988-11-30 | Traditional | PDF ↗ |
| K883305 | BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY | Binax, Inc. | 1988-10-06 | Traditional | PDF ↗ |
| K883279 | PHASE II FSH KIT | Vitek Systems, Inc. | 1988-09-09 | Traditional | PDF ↗ |
| K881142 | AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST | Amersham Corp. | 1988-07-21 | Traditional | PDF ↗ |
| K881596 | FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 | Medix Biotech, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K881123 | ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. | Nichols Institute Diagnostics | 1988-04-28 | Traditional | PDF ↗ |
| K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1987-10-20 | Traditional | PDF ↗ |
| K872309 | MICROMEDIC COMBOSTAT LH/FSH KIT | Micromedic Systems | 1987-07-31 | Traditional | PDF ↗ |
| K872627 | FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH | Serono Diagnostics, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K871317 | FOLLICLE STIMULATING HORMONE (HFSH) | Immuchem Corp. | 1987-05-20 | Traditional | PDF ↗ |
| K870520 | TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K863928 | TERUMO SENSIBEAD EIA FSH KIT | Terumo Medical Corp. | 1986-12-04 | Traditional | PDF ↗ |
| K864080 | UBI MAGIWEL(TM) FSH QUANTITATIVE | United Biotech, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K863678 | FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | 1986-10-16 | Traditional | PDF ↗ |
| K862813 | FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT | Serono Diagnostics, Inc. | 1986-09-16 | Traditional | PDF ↗ |
| K862439 | SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA | Boots-Celltech Diagnostics, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862043 | DELFIA (TM) HFSH KIT | Lkb Instruments, Inc. | 1986-06-24 | Traditional | PDF ↗ |
| K854837 | LEE-BEAD BETA FSH (EIA) | Leeco Diagnostics, Inc. | 1986-01-13 | Traditional | PDF ↗ |
| K854651 | PARAAMAX CHLORIDE DETERMINATION BY ISE | American Dade | 1985-12-13 | Traditional | PDF ↗ |
| K851361 | AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM | Amersham Corp. | 1985-05-07 | Traditional | PDF ↗ |
| K844066 | COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH | Clinetics Corp. | 1985-01-18 | Traditional | PDF ↗ |
| K843930 | IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I | Euro-Diagnostics BV | 1984-10-30 | Traditional | PDF ↗ |
| K842444 | FSH RIA | Syncor Intl. Corp. | 1984-08-17 | Traditional | PDF ↗ |
| K840230 | FSH QUIK RIA KIT | Pacific Biotech, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K834038 | RIANEN FOLLICLE STIMULATING HORMONE | New England Nuclear | 1984-01-30 | Traditional | PDF ↗ |
| K833852 | FSH RIA | Syncor Intl. Corp. | 1984-01-13 | Traditional | PDF ↗ |
| K831742 | QUANTIMUNE HFSH RIA HUMAN FOLLICLE- | Bio-Rad | 1983-07-18 | Traditional | PDF ↗ |
| K823379 | 125-I FSH RADIOIMMUNOASSAY KIT | Clinetics Corp. | 1982-12-22 | Traditional | PDF ↗ |
| K822227 | IMMO PHASE FSH RADIOIMMUNOASSAY | Corning Medical & Scientific | 1982-08-16 | Traditional | PDF ↗ |
| K821611 | GAMMADAB [125] FSH RADIOIMMUNAY KIT | Clinical Assays, Inc. | 1982-06-24 | Traditional | PDF ↗ |
| K820754 | AMERLEX ESH KIT | Amersham Corp. | 1982-04-15 | Traditional | PDF ↗ |
| K820740 | MR1 FOLLITROPIN RIA KIT | Microanalytic Research, Inc. | 1982-04-06 | Traditional | PDF ↗ |
| K820358 | FOLLICLE STIMULATING HORMONE KIT | Pcl-Ria, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K820048 | FSH RADIOIMMUNOASSAY TEST SYSTEM | Monobind | 1982-02-04 | Traditional | PDF ↗ |
| K813086 | ANDRIA-FSH RIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K811993 | RADIOIMMUNOASSAY, FOLLICLE STIMULATING | Endocrine-Metabolic Center | 1981-08-03 | Traditional | PDF ↗ |
| K811905 | FOLLICLE STIMULATING HORMONE DIRECT RIA | Immunalysis Corporation | 1981-07-23 | Traditional | PDF ↗ |
| K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM | Pcl-Ria, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K810663 | LEECO FSH-QUANT DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1981-03-27 | Traditional | PDF ↗ |
| K810381 | HTSH RIABEAD DIAGNOSTIC KIT | Abbott Laboratories | 1981-02-26 | Traditional | PDF ↗ |
| K803279 | FOLLICE STIMULATING HORMONE-RADIOIMM. KT | Immuno Nuclear Corp. | 1981-01-16 | Traditional | PDF ↗ |
| K800107 | FOLLICLE STIMULATING HORMONE | Radioimmunoassay, Inc. | 1980-02-13 | Traditional | PDF ↗ |
| K792233 | CENTRIA FSH RIA | Union Carbide Corp. | 1980-01-21 | Traditional | PDF ↗ |
| K792063 | FOLLICLE STIMULATING HORMONE (FSH) KIT | Cis Radiopharmaceuticals, Inc. | 1979-11-20 | Traditional | PDF ↗ |
| K791836 | QUANTIMUNE HFSH RIA | Bio-Rad | 1979-10-01 | Traditional | PDF ↗ |
| K780870 | RIA SYSTEM FOR HUMAN F-S HORMONE | Calbiochem-Behring Corp. | 1978-06-22 | Traditional | PDF ↗ |
| K771756 | FOLLICLE-STIMULATING HORMONE | Nichols Institute Diagnostics | 1977-10-18 | Traditional | PDF ↗ |
| K760373 | RADIOASSAY KIT, IM.72 FSH | Amersham Corp. | 1976-11-01 | Traditional | PDF ↗ |
Product code CGJ · Class I · Clinical Chemistry. Data: openFDA.