Panels › Clinical Chemistry › Product code CGJ · Class 1
Radioimmunoassay, Follicle-Stimulating Hormone
Regulation 862.1300
0510(k)s in 12 months (88 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in CGJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 30, 2005 | K052662 | ONE STEP FSH MENOPAUSAL TEST Ind Diagnostic, Inc., CA | CGJ |
| Feb 25, 2005 | K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 Phamatech, Inc. | CGJ |
| Jun 17, 2004 | K041165 | FSH MENOPAUSE PREDICTOR TEST ACON Laboratories, Inc. | CGJ |
| May 20, 2004 | K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 Phamatech, Inc. | CGJ |
| Jul 30, 2003 | K030058 | EARLYDETECT MENOPAUSE TEST FOR FSH Early Detect, Inc. | CGJ |
| Jan 12, 2001 | K002450 | GENUA MENOPAUSE MONITOR TEST KIT Genua 1944, Inc. | CGJ |
| Sep 2, 1997 | K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) Monobind | CGJ |
| Feb 14, 1997 | K970085 | SEALITE SCIENCES AQUALITE FSH Sealite Sciences, Inc. | CGJ |
| Feb 4, 1997 | K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) Johnson & Johnson Clinical Diagnostics, Inc. | CGJ |
| Dec 16, 1996 | K964693 | ELECSYS FSH ASSAY Boehringer Mannheim Corp. | CGJ |
| Sep 9, 1996 | K962118 | DSL ACTIVE FSH IRMA Diagnostic Systems Laboratories, Inc. | CGJ |
| Jul 3, 1995 | K952285 | AMERLITE FSH ASSAY Johnson & Johnson Clinical Diagnostics, Inc. | CGJ |
| Dec 28, 1994 | K943437 | AQUALITE FSH Sealite Sciences, Inc. | CGJ |
| Jul 20, 1994 | K941221 | DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE Dupont Medical Products | CGJ |
| Jun 21, 1994 | K935612 | AXSYM FOLLICLE STIMULATING HORMONE (FSH) Abbott Laboratories | CGJ |
| Mar 3, 1994 | K940005 | ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY Bio-Rad Laboratories, Inc. | CGJ |
| Sep 21, 1993 | K930304 | COBAS CORE FSH EIA Roche Diagnostic Systems, Inc. | CGJ |
| Oct 5, 1992 | K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT Icn Biomedicals, Inc. | CGJ |
| Jun 16, 1992 | K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Biomerieux Vitek, Inc. | CGJ |
| Jun 9, 1992 | K921704 | IMMULITE(R) FSH Cirrus Diagnostics, Inc. | CGJ |
| Mar 26, 1992 | K920917 | ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY Bio Clinic Co. | CGJ |
| Dec 18, 1991 | K915208 | FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 Medix Biotech, Inc. | CGJ |
| Aug 12, 1991 | K912804 | FSH IRMA IMMUNOMAG Pantex, Div. Bio-Analysis, Inc. | CGJ |
| Apr 16, 1991 | K911409 | OPUS FSH Pb Diagnostic Systems, Inc. | CGJ |
| Feb 4, 1991 | K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY London Diagnostics, Inc. | CGJ |
| Dec 27, 1990 | K905592 | AFFINITY FSH TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | CGJ |
| Nov 20, 1990 | K904649 | CIBA CORNING ACS FSH IMMUNOASSAY Ciba Corning Diagnostics Corp. | CGJ |
| Oct 26, 1990 | K904405 | BIOCLONES ELEGANCE FSH ELISA KIT Bioclone Australia Pty , Ltd. | CGJ |
| May 10, 1990 | K901345 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 Medix Biotech, Inc. | CGJ |
| Mar 15, 1990 | K900763 | ENZYMUN TEST(R) FSH Boehringer Mannheim Corp. | CGJ |
| Jan 11, 1990 | K896864 | FOLLICLE STIMULATING HORMONE-EIA-XT In Vitro Diagnostics, Inc. | CGJ |
| Jan 2, 1990 | K896640 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CGJ |
| Oct 31, 1989 | K895005 | MILENIA(TM) FSH (MKFS1,5) Diagnostic Products Corp. | CGJ |
| Oct 23, 1989 | K895108 | FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. Bd Becton Dickinson Vacutainer Systems Preanalytic | CGJ |
| Sep 13, 1989 | K894761 | TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. | CGJ |
| Aug 17, 1989 | K893976 | COAT-A-COUNT (TM) FSH IRMA Diagnostic Products Corp. | CGJ |
| Jun 9, 1989 | K892706 | SR1 (FSH) IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | CGJ |
| Feb 10, 1989 | K890135 | IMX FOLLICLE STIMULATING HORMONE (FSH) Abbott Laboratories | CGJ |
| Jan 17, 1989 | K884708 | FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT Cyberfluor, Inc., CA | CGJ |
| Dec 6, 1988 | K884687 | CIBA CORNING MAGIC LITE FSH IMMUNOASSAY Ciba Corning Diagnostics Corp. | CGJ |
| Nov 30, 1988 | K883745 | IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES Diagnostic Products Corp. | CGJ |
| Oct 6, 1988 | K883305 | BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY Binax, Inc. | CGJ |
| Sep 9, 1988 | K883279 | PHASE II FSH KIT Vitek Systems, Inc. | CGJ |
| Jul 21, 1988 | K881142 | AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST Amersham Corp. | CGJ |
| May 27, 1988 | K881596 | FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 Medix Biotech, Inc. | CGJ |
| Apr 28, 1988 | K881123 | ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. Nichols Institute Diagnostics | CGJ |
| Oct 20, 1987 | K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | CGJ |
| Jul 31, 1987 | K872309 | MICROMEDIC COMBOSTAT LH/FSH KIT Micromedic Systems | CGJ |
| Jul 21, 1987 | K872627 | FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH Serono Diagnostics, Inc. | CGJ |
| May 20, 1987 | K871317 | FOLLICLE STIMULATING HORMONE (HFSH) Immuchem Corp. | CGJ |
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