Iq T4 Immunoassay
by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)
Active
510(k) K864560
Overview
The Iq T4 Immunoassay is a radioimmunoassay device used for the measurement of total thyroxine. It functions as a diagnostic tool within the field of clinical chemistry.
This device is regulated under FDA 510K clearance. It is classified as a class 2 medical device under regulation number 862.1700.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864560 | Date16 Dec 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CDX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1700
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
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