Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1300](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1300) → CGJ — Radioimmunoassay, Follicle-Stimulating Hormone # CGJ · Radioimmunoassay, Follicle-Stimulating Hormone _Clinical Chemistry · 21 CFR 862.1300 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ ## Overview - **Product Code:** CGJ - **Device Name:** Radioimmunoassay, Follicle-Stimulating Hormone - **Regulation:** [21 CFR 862.1300](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1300) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K052662.md) | ONE STEP FSH MENOPAUSAL TEST | Ind Diagnostic, Inc. | Nov 30, 2005 | SESE | | [K043599](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K043599.md) | MOMENTS MENOPAUSE CHECK, MODEL 9113 | Phamatech, Inc. | Feb 25, 2005 | SESE | | [K041165](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K041165.md) | FSH MENOPAUSE PREDICTOR TEST | ACON Laboratories, Inc. | Jun 17, 2004 | SESE | | [K040575](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K040575.md) | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | Phamatech, Inc. | May 20, 2004 | SESE | | [K030058](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K030058.md) | EARLYDETECT MENOPAUSE TEST FOR FSH | Early Detect, Inc. | Jul 30, 2003 | SESE | | [K002450](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K002450.md) | GENUA MENOPAUSE MONITOR TEST KIT | Genua 1944, Inc. | Jan 12, 2001 | SESE | | [K972720](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K972720.md) | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | Monobind | Sep 2, 1997 | SESE | | [K970085](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K970085.md) | SEALITE SCIENCES AQUALITE FSH | Sealite Sciences, Inc. | Feb 14, 1997 | SESE | | [K964720](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K964720.md) | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) | Johnson & Johnson Clinical Diagnostics, Inc. | Feb 4, 1997 | SESE | | [K964693](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K964693.md) | ELECSYS FSH ASSAY | Boehringer Mannheim Corp. | Dec 16, 1996 | SESE | | [K962118](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K962118.md) | DSL ACTIVE FSH IRMA | Diagnostic Systems Laboratories, Inc. | Sep 9, 1996 | SESE | | [K952285](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K952285.md) | AMERLITE FSH ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | Jul 3, 1995 | SESE | | [K943437](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K943437.md) | AQUALITE FSH | Sealite Sciences, Inc. | Dec 28, 1994 | SESE | | [K941221](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K941221.md) | DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE | Dupont Medical Products | Jul 20, 1994 | SESE | | [K935612](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K935612.md) | AXSYM FOLLICLE STIMULATING HORMONE (FSH) | Abbott Laboratories | Jun 21, 1994 | SESE | | [K940005](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K940005.md) | ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY | Bio-Rad Laboratories, Inc. | Mar 3, 1994 | SESE | | [K930304](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K930304.md) | COBAS CORE FSH EIA | Roche Diagnostic Systems, Inc. | Sep 21, 1993 | SESE | | [K922376](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K922376.md) | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | Icn Biomedicals, Inc. | Oct 5, 1992 | SESE | | [K921746](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K921746.md) | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | Jun 16, 1992 | SESE | | [K921704](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K921704.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com