Product code CGJ
- Device name
- Radioimmunoassay, Follicle-Stimulating Hormone
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1300
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052662 | ONE STEP FSH MENOPAUSAL TEST | Ind Diagnostic, Inc. | 2005-11-30 |
| K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 | Phamatech, Inc. | 2005-02-25 |
| K041165 | FSH MENOPAUSE PREDICTOR TEST | ACON Laboratories, Inc. | 2004-06-17 |
| K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | Phamatech, Inc. | 2004-05-20 |
| K030058 | EARLYDETECT MENOPAUSE TEST FOR FSH | Early Detect, Inc. | 2003-07-30 |
| K002450 | GENUA MENOPAUSE MONITOR TEST KIT | Genua 1944, Inc. | 2001-01-12 |
| K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | Monobind | 1997-09-02 |
| K970085 | SEALITE SCIENCES AQUALITE FSH | Sealite Sciences, Inc. | 1997-02-14 |
| K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-04 |
| K964693 | ELECSYS FSH ASSAY | Boehringer Mannheim Corp. | 1996-12-16 |
| K962118 | DSL ACTIVE FSH IRMA | Diagnostic Systems Laboratories, Inc. | 1996-09-09 |
| K952285 | AMERLITE FSH ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-03 |
| K943437 | AQUALITE FSH | Sealite Sciences, Inc. | 1994-12-28 |
| K941221 | DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE | Dupont Medical Products | 1994-07-20 |
| K935612 | AXSYM FOLLICLE STIMULATING HORMONE (FSH) | Abbott Laboratories | 1994-06-21 |
| K940005 | ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY | Bio-Rad Laboratories, Inc. | 1994-03-03 |
| K930304 | COBAS CORE FSH EIA | Roche Diagnostic Systems, Inc. | 1993-09-21 |
| K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | Icn Biomedicals, Inc. | 1992-10-05 |
| K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | 1992-06-16 |
| K921704 | IMMULITE(R) FSH | Cirrus Diagnostics, Inc. | 1992-06-09 |
| K920917 | ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY | Bio Clinic Co. | 1992-03-26 |
| K915208 | FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 | Medix Biotech, Inc. | 1991-12-18 |
| K912804 | FSH IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-08-12 |
| K911409 | OPUS FSH | Pb Diagnostic Systems, Inc. | 1991-04-16 |
| K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY | London Diagnostics, Inc. | 1991-02-04 |
| K905592 | AFFINITY FSH TEST SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-12-27 |
| K904649 | CIBA CORNING ACS FSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1990-11-20 |
| K904405 | BIOCLONES ELEGANCE FSH ELISA KIT | Bioclone Australia Pty , Ltd. | 1990-10-26 |
| K901345 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 | Medix Biotech, Inc. | 1990-05-10 |
| K900763 | ENZYMUN TEST(R) FSH | Boehringer Mannheim Corp. | 1990-03-15 |
Related GUDID Devices#
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| 14562185400318 | CL AIA-PACK FSH TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 04562185400311 | CL AIA-PACK FSH TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 04048474012880 | FSH ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-22 |
| 07613336217801 | Elecsys FSH | Roche Diagnostics GmbH | 2024-08-19 |
| 04048474053555 | FSH | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474040982 | FSH ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 00840239053558 | FSH | DRG International Inc | 2023-08-26 |
| 00840239012883 | FSH ELISA | DRG International Inc | 2023-08-22 |
| 15099590575236 | Access hFSH | Beckman Coulter, Inc. | 2023-06-26 |
| B261CANFSH40600 | DBC Follicle Stimulating Hormone (FSH) ELISA | Diagnostics Biochem Canada Inc | 2022-11-15 |
| 06925912718499 | iFlash-FSH | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| B512210011 | One Step Menopausal Test | UNIVERSAL MEDITECH INC. | 2021-10-15 |
| 07613336170380 | Elecsys FSH | Roche Diagnostics GmbH | 2021-10-06 |
| 07613336170373 | Elecsys FSH | Roche Diagnostics GmbH | 2021-10-06 |
| 15099590575250 | Access hFSH Calibrators | Beckman Coulter, Inc. | 2021-09-03 |
| 00840239040985 | FSH ELISA | DRG International Inc | 2021-06-07 |
| 00404847412888 | FSH ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| B24211FSHHUE010 | Follicle Stimulating Hormone (FSH) ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| 00630414167442 | IMMULITE 2000 FSH Kit Domestic 600T | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414167435 | IMMULITE 2000 FSH Kit Domestic 200T | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414126210 | ADVIA Centaur® FSH MCM | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414293660 | Atellica IM FSH | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 14560189210391 | ST AIA-PACK FSH | TOSOH CORPORATION | 2019-07-24 |
| 24560189210398 | ST AIA-PACK FSH | TOSOH CORPORATION | 2019-07-24 |
| 14560189211305 | AIA-PACK FSH Calibrator Set | TOSOH CORPORATION | 2019-07-24 |
| 14560189211299 | AIA-PACK FSH Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 04560189211292 | AIA-PACK FSH Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 04560189211308 | AIA-PACK FSH Calibrator Set | TOSOH CORPORATION | 2019-07-24 |
| 04015630939701 | Elecsys FSH | Roche Diagnostics GmbH | 2017-04-21 |