FSH Enzyme Immunoassay Test Kit No. MB-1057
FDA 510(k) K881596 · Medix Biotech, Inc.
510(k) numberK881596
Submission
- Device name
- FSH Enzyme Immunoassay Test Kit No. MB-1057
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- April 12, 1988
- Decision date
- May 27, 1988
- 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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| K964720 | Vitros Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005)CGJ · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/04/1997SE |
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Questions and answers
When was FSH Enzyme Immunoassay Test Kit No. MB-1057 cleared by the FDA?
FSH Enzyme Immunoassay Test Kit No. MB-1057 (K881596) received a 510(k) decision of Substantially Equivalent on May 27, 1988, 45 days after the submission was received.
What is the product code of K881596?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.