Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CGJ — Predicate Candidate Screening
88 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
101 days90th percentile
88clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052662 | ONE STEP FSH MENOPAUSAL TEST | Ind Diagnostic, Inc. | 2005-11-30 | 64 | 1 |
| K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 | Phamatech, Inc. | 2005-02-25 | 58 | 0 |
| K041165 | FSH MENOPAUSE PREDICTOR TEST | ACON Laboratories, Inc. | 2004-06-17 | 44 | 0 |
| K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | Phamatech, Inc. | 2004-05-20 | 77 | 0 |
| K030058 | EARLYDETECT MENOPAUSE TEST FOR FSH | Early Detect, Inc. | 2003-07-30 | 204 | 0 |
| K002450 | GENUA MENOPAUSE MONITOR TEST KIT | Genua 1944, Inc. | 2001-01-12 | 156 | 0 |
| K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300 | Monobind | 1997-09-02 | 43 | 0 |
| K970085 | SEALITE SCIENCES AQUALITE FSH | Sealite Sciences, Inc. | 1997-02-14 | 35 | 0 |
| K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 100 | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-04 | 71 | 0 |
| K964693 | ELECSYS FSH ASSAY | Boehringer Mannheim Corp. | 1996-12-16 | 24 | 0 |
| K962118 | DSL ACTIVE FSH IRMA | Diagnostic Systems Laboratories, Inc. | 1996-09-09 | 101 | 0 |
| K952285 | AMERLITE FSH ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-03 | 48 | 0 |
| K943437 | AQUALITE FSH | Sealite Sciences, Inc. | 1994-12-28 | 163 | 0 |
| K941221 | DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORM | Dupont Medical Products | 1994-07-20 | 128 | 0 |
| K935612 | AXSYM FOLLICLE STIMULATING HORMONE (FSH) | Abbott Laboratories | 1994-06-21 | 211 | 1 |
| K940005 | ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY | Bio-Rad Laboratories, Inc. | 1994-03-03 | 59 | 0 |
| K930304 | COBAS CORE FSH EIA | Roche Diagnostic Systems, Inc. | 1993-09-21 | 243 | 0 |
| K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | Icn Biomedicals, Inc. | 1992-10-05 | 138 | 0 |
| K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | 1992-06-16 | 64 | 1 |
| K921704 | IMMULITE(R) FSH | Cirrus Diagnostics, Inc. | 1992-06-09 | 60 | 0 |
| K920917 | ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY | Bio Clinic Co. | 1992-03-26 | 27 | 0 |
| K915208 | FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 | Medix Biotech, Inc. | 1991-12-18 | 30 | 0 |
| K912804 | FSH IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-08-12 | 48 | 0 |
| K911409 | OPUS FSH | Pb Diagnostic Systems, Inc. | 1991-04-16 | 15 | 0 |
| K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY | London Diagnostics, Inc. | 1991-02-04 | 38 | 0 |
| K905592 | AFFINITY FSH TEST SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-12-27 | 14 | 0 |
| K904649 | CIBA CORNING ACS FSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1990-11-20 | 40 | 0 |
| K904405 | BIOCLONES ELEGANCE FSH ELISA KIT | Bioclone Australia Pty , Ltd. | 1990-10-26 | 31 | 0 |
| K901345 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 | Medix Biotech, Inc. | 1990-05-10 | 49 | 0 |
| K900763 | ENZYMUN TEST(R) FSH | Boehringer Mannheim Corp. | 1990-03-15 | 27 | 0 |
| K896864 | FOLLICLE STIMULATING HORMONE-EIA-XT | In Vitro Diagnostics, Inc. | 1990-01-11 | 36 | 0 |
| K896640 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1990-01-02 | 39 | 0 |
| K895005 | MILENIA(TM) FSH (MKFS1,5) | Diagnostic Products Corp. | 1989-10-31 | 84 | 0 |
| K895108 | FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-23 | 69 | 0 |
| K894761 | TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | 1989-09-13 | 48 | 0 |
| K893976 | COAT-A-COUNT (TM) FSH IRMA | Diagnostic Products Corp. | 1989-08-17 | 76 | 0 |
| K892706 | SR1 (FSH) IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-06-09 | 56 | 0 |
| K890135 | IMX FOLLICLE STIMULATING HORMONE (FSH) | Abbott Laboratories | 1989-02-10 | 28 | 0 |
| K884708 | FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | 1989-01-17 | 69 | 0 |
| K884687 | CIBA CORNING MAGIC LITE FSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1988-12-06 | 28 | 0 |
| K883745 | IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES | Diagnostic Products Corp. | 1988-11-30 | 90 | 0 |
| K883305 | BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY | Binax, Inc. | 1988-10-06 | 63 | 0 |
| K883279 | PHASE II FSH KIT | Vitek Systems, Inc. | 1988-09-09 | 37 | 0 |
| K881142 | AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST | Amersham Corp. | 1988-07-21 | 126 | 0 |
| K881596 | FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 | Medix Biotech, Inc. | 1988-05-27 | 45 | 0 |
| K881123 | ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. | Nichols Institute Diagnostics | 1988-04-28 | 43 | 0 |
| K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1987-10-20 | 77 | 0 |
| K872309 | MICROMEDIC COMBOSTAT LH/FSH KIT | Micromedic Systems | 1987-07-31 | 45 | 0 |
| K872627 | FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH | Serono Diagnostics, Inc. | 1987-07-21 | 15 | 0 |
| K871317 | FOLLICLE STIMULATING HORMONE (HFSH) | Immuchem Corp. | 1987-05-20 | 48 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda