510(k) K971662 ยท GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
ELVIS HSV ID/TYPING TEST SYSTEM
| Applicant | Diagnostic Hybrids, Inc., Athens OH, US |
| Decision | Substantially Equivalent, Nov 18, 1997 |
| Received | Apr 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971662
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.