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.
Recent Cleared Devices (20 of 88)
Showing 20 most recent of 88 cleared devices.
| 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 |
Top Applicants
- Amersham Corp. — 4 clearances
- Medix Biotech, Inc. — 4 clearances
- Abbott Laboratories — 3 clearances
- Diagnostic Products Corp. — 3 clearances
- Nichols Institute Diagnostics — 3 clearances
