510(k) K853307 ยท GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
DIRECT ELISA FOR HERPES SIMPLEX VIRUS
| Applicant | Fairleigh Dickinson Laboratories, Inc., Abilene TX, US |
| Decision | Substantially Equivalent, Dec 23, 1985 |
| Received | Aug 7, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853307
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.