V-Trend Qc Tdm Control Serum 1, 2, 3.
by Texas Immunology, Inc. 510(k)
Active
510(k) K862817
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862817 | Date19 Aug 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 11 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DIF
- Device Class
- Class I
- Regulation
- 21 CFR Part 862.3280
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent