Neonatal Ntsh Radioimmunoassay Sys
by Corning Medical & Scientific 510(k)
Active
510(k) K830036
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830036 | Date28 Jan 1983 | 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- Withdrawn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, 24 Sep 2026
The Neonatal Ntsh Radioimmunoassay Sys is a radioimmunoassay device for thyroid-stimulating hormone. It is classified as a device class 2 and is used in clinical chemistry. The device is substantially equivalent to other devices and has a regulation number of 862.1690.
The device is supplied by Corning Medical & Scientific and has a product code of JLW. It was cleared on January 28, 1983, with a clearance type of traditional and has an FDA 510K number of K830036. The device is used in clinical settings and is subject to regulation by the FDA.