Identifiers
- 510(k) Number
- K834049 FDA 510(k)
- FDA Product Code
- CDP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1710 FDA 510(k)
- Regulation Number
- 862.1710 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a radioimmunoassay for total triiodothyronine (T3). It is used in clinical chemistry for the measurement of T3 levels.
It is supplied as a test kit for in vitro diagnostic use. The device received FDA 510(k) clearance (K834049) on January 30, 1984, and is classified as a Class II device under regulation number 862.1710 with product code CDP.
Frequently asked questions
What is the ENDAB T3 device used for?
The ENDAB T3 is a radioimmunoassay used in clinical chemistry for the measurement of total triiodothyronine (T3) levels, as it is designed to quantify T3 in patient samples for diagnostic evaluation.
How is the ENDAB T3 supplied and for what type of use?
The ENDAB T3 is supplied as a test kit for in vitro diagnostic use, meaning it is intended to be used outside the body in a laboratory setting to analyze specimens such as blood or serum.
What regulatory clearance does the ENDAB T3 have and when was it granted?
The ENDAB T3 received FDA 510(k) clearance under submission K834049 on January 30, 1984, and is classified as a Class II device under regulation 862.1710 with product code CDP.
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 T3 (K834049) — FDA 510 (k) | Innolitics, ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY (K802066) — FDA 510(k ..., Immunotech ENDAB EIA Kit (10508) - Triiodothyronine (T3), ENDAB - Immunotech Corporation Trademark Registration, Immunotech ENDAB EIA Kit Diagnostic Test | NextWaveMD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K834049 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunotech Corp.
Sources (1)
- FDA 510(k) K834049 24 fields · synced Sep 27, 2026