Nichols Advantage Chemiluminescence Thyroid Stimulating Hormone Third Generation Kit
by Nichols Institute Diagnostics 510(k)
Active
510(k) K961650
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961650 | Date16 Jul 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JLW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1690
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Nichols Advantage Chemiluminescence Thyroid Stimulating Hormone Third Generation Kit is a radioimmunoassay device used for the measurement of thyroid-stimulating hormone. It is classified as a device in the clinical chemistry medical specialty.
The device is supplied as a kit and is intended for use in a clinical setting. It has been assigned a regulation number of 862.1690 and has been cleared by the FDA with a K number of K961650. The device is classified as a class 2 device with a traditional clearance type.