125-I FSH Radioimmunoassay Kit
FDA 510(k) K823379 · Clinetics Corp.
510(k) numberK823379
Submission
- Device name
- 125-I FSH Radioimmunoassay Kit
- Applicant
- Clinetics Corp.
Mchenry, IL, US - Received
- November 12, 1982
- Decision date
- December 22, 1982
- 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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|---|---|---|---|
| K052662 | One Step FSH Menopausal TestCGJ · Traditional | Ind Diagnostic, Inc. | 11/30/2005SE |
| K043599 | Moments Menopause Check, Model 9113CGJ · Special | Phamatech, Inc. | 02/25/2005SE |
| K041165 | FSH Menopause Predictor TestCGJ · Traditional | ACON Laboratories, Inc. | 06/17/2004SE |
| K040575 | Pharmatech Menopause Check, Models 9111 and 9112CGJ · Traditional | Phamatech, Inc. | 05/20/2004SE |
| K030058 | Earlydetect Menopause Test for FSHCGJ · Traditional | Early Detect, Inc. | 07/30/2003SE |
| 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 |
|---|---|---|
| K862180 | Modified Cotropin Radioimmunoassay KitCEP · Traditional | 07/07/1986SE |
| K844066 | Cotropin Stimulataneous 57 Co-Lh 125I I-FshCGJ · Traditional | 01/18/1985SE |
| K841580 | TSH Receptor Antibody Kit 125I TSHJZO · Traditional | 10/22/1984SE |
| K833934 | Adrenocorticotropic Hormone TestCKG · Traditional | 04/04/1984SE |
| K830357 | Radioimmunoassay Immunoglobulins D.EDGC · Traditional | 03/17/1983SE |
| K823380 | 125-I LH Radioimmunoassay KitCEP · Traditional | 12/22/1982SE |
| K822152 | HCG Beta Ria KitJHI · Traditional | 09/02/1982SE |
| K801306 | Clinetics Pca ColumnDHX · Traditional | 09/26/1980SE |
Questions and answers
When was 125-I FSH Radioimmunoassay Kit cleared by the FDA?
125-I FSH Radioimmunoassay Kit (K823379) received a 510(k) decision of Substantially Equivalent on December 22, 1982, 40 days after the submission was received.
What is the product code of K823379?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.