Corning Magic Mab Hcg Radioimmunoassay
by Corning Medical & Scientific 510(k)
Active
510(k) K854024
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854024 | Date26 Nov 1985 | 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- Withdrawn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
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Corning Magic Mab Hcg Radioimmunoassay is a device used to detect human chorionic gonadotropin (HCG) in clinical samples. It is intended for prescription use in clinical chemistry applications.
This device is supplied as a single-use product and is regulated under FDA 510(k) clearance. It is not sterilized and requires proper storage conditions as specified by the manufacturer.