RIA Kit, Neonatal T4
by Serono Laboratories, Inc. 510(k)
Active
510(k) K782103
Overview
This device is a radioimmunoassay (RIA) kit for the measurement of total thyroxine (T4) in neonatal specimens. It is classified as a Class II medical device under the Clinical Chemistry specialty and is identified by the product code CDX.
The kit received traditional 510(k) clearance from the FDA on January 17, 1979, under K782103, and is substantially equivalent to a legally marketed predicate device. It is manufactured by Serono Laboratories, Inc. in McHenry, Illinois, and is intended for use in clinical laboratory settings for in vitro diagnostic testing.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK782103 | Date17 Jan 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- Withdrawn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
- CDX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1700
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent