510(k) K854488 ยท GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
ORTHO HSV ANTIGEN ELISA TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Feb 4, 1986 |
| Received | Nov 8, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854488
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.