Centria Hpl Ria
by Union Carbide Corp. 510(k)
Active
510(k) K791854
Overview
Radioimmunoassay, Human Placental Lactogen is a device used in clinical chemistry for the quantitative measurement of human placental lactogen in serum or plasma specimens. It operates as a radioimmunoassay system to detect and quantify this specific hormone.
The device is supplied as a traditional 510(k) cleared in vitro diagnostic reagent system, classified as Class II under regulation number 862.1585 with product code JMF. It received FDA 510(k) clearance K791854 on October 1, 1979, and is intended for use in clinical laboratory settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791854 | Date1 Oct 1979 | 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- Withdrawn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
- JMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1585
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent