Follicle Stimulating Hormone
FDA 510(k) K800107 · Radioimmunoassay, Inc.
510(k) numberK800107
Submission
- Device name
- Follicle Stimulating Hormone
- Applicant
- Radioimmunoassay, Inc.
Mchenry, IL, US - Received
- January 16, 1980
- Decision date
- February 13, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGJ – Radioimmunoassay, Follicle-Stimulating Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Specialty
- Clinical Chemistry
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| K002450 | Genua Menopause Monitor Test KitCGJ · Traditional | Genua 1944, Inc. | 01/12/2001SE |
| K972720 | Follicle Stimulating Hormone (FSH) Microplate Elisa (425-300)CGJ · Traditional | Monobind | 09/02/1997SE |
| K970085 | Sealite Sciences Aqualite FSHCGJ · Traditional | Sealite Sciences, Inc. | 02/14/1997SE |
| K964720 | Vitros Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005)CGJ · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/04/1997SE |
| K964693 | Elecsys FSH AssayCGJ · Traditional | Boehringer Mannheim Corp. | 12/16/1996SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K802135 | Testosterone Radioimmunoassy KitCDZ · Traditional | 10/10/1980SE |
| K800106 | Luteinizing Hormone Radioimmunoassay SysCEP · Traditional | 02/13/1980SE |
| K792539 | Triiodothyronine Ria SystemCDP · Traditional | 01/16/1980SE |
| K792154 | Thyroid Stimulating HormoneJLW · Traditional | 11/13/1979SE |
| K792153 | Digoxin Radioimmunoassay SystemDPB · Traditional | 11/13/1979SE |
| K792036 | Cortisol Radioimmunoassay SystemCGR · Traditional | 10/30/1979SE |
| K780672 | 125 I-T4 Ria ReagentCDX · Traditional | 06/06/1978SE |
| K780671 | 125 I-T3 Uptake ReagentCEE · Traditional | 06/06/1978SE |
Questions and answers
When was Follicle Stimulating Hormone cleared by the FDA?
Follicle Stimulating Hormone (K800107) received a 510(k) decision of Substantially Equivalent on February 13, 1980, 28 days after the submission was received.
What is the product code of K800107?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.