Radioimmunoassay, Follicle Stimulating
FDA 510(k) K811993 · Endocrine-Metabolic Center
510(k) numberK811993
Submission
- Device name
- Radioimmunoassay, Follicle Stimulating
- Applicant
- Endocrine-Metabolic Center
Mchenry, IL, US - Received
- July 14, 1981
- Decision date
- August 3, 1981
- 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 |
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| K810948 | Radioimmunoassay Thyroid Stim. Horm. KitJLW · Traditional | 04/17/1981SE |
| K810351 | Radioimmunoassay, Total TriiodothronieCDP · Traditional | 02/23/1981SE |
| K800188 | EMC-M-180, T3 Uptake - 100 TubesKHQ · Traditional | 02/13/1980SE |
| K800187 | EMC-M-175, Thyroxine - 100 TubesCDX · Traditional | 02/13/1980SE |
| K790602 | Ria, DIGNXIN-125-IDPB · Traditional | 07/30/1979SE |
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Questions and answers
When was Radioimmunoassay, Follicle Stimulating cleared by the FDA?
Radioimmunoassay, Follicle Stimulating (K811993) received a 510(k) decision of Substantially Equivalent on August 3, 1981, 20 days after the submission was received.
What is the product code of K811993?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.