Modified FSH Enzyme Immunoassay Test Kit
FDA 510(k) K896640 · Medix Biotech, Inc.
510(k) numberK896640
Submission
- Device name
- Modified FSH Enzyme Immunoassay Test Kit
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- November 24, 1989
- Decision date
- January 2, 1990
- 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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| K924259 | Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100JHI · Traditional | 11/25/1992SE |
| K922047 | Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064DGC · Traditional | 08/05/1992SE |
| K921700 | TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093JLW · Traditional | 06/29/1992SE |
| K920712 | Medix Biotech Throxine Enzyme Immunoassay Test KitKLI · Traditional | 03/27/1992SE |
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Questions and answers
When was Modified FSH Enzyme Immunoassay Test Kit cleared by the FDA?
Modified FSH Enzyme Immunoassay Test Kit (K896640) received a 510(k) decision of Substantially Equivalent on January 2, 1990, 39 days after the submission was received.
What is the product code of K896640?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.