Identifiers
- 510(k) Number
- K810192 FDA 510(k)
- FDA Product Code
- CGR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1205 FDA 510(k)
- Regulation Number
- 862.1205 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Endab Cortisol Kit is a radioimmunoassay device used for the quantitative determination of cortisol. It is classified as a clinical chemistry device intended for diagnostic laboratory testing.
This device is regulated under FDA 510(k) number K810192. It is categorized as a class 2 medical device under regulation number 862.1205.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ENDAB CORTISOL KIT (K810192) — FDA 510 (k) | Innolitics, ENDAB CORTISOL KIT 510 (k) K810192 - FDA.report, PDF K810192 ENDAB CORTISOL KIT - 510kdatabase.net, Immunotech FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K810192 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunotech Corp.
Sources (1)
- FDA 510(k) K810192 24 fields · synced Sep 21, 2026