Multicode - Rtx Herpes Simplex Virus 1 and 2 Kit, Model 3711
by Eragen Biosciences 510(k)
Active
510(k) K100336
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100336 | Date12 May 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- OQO
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3305
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent