510(k) K964015 ยท MJM Dna Probe, Gardnerella Vaginalis
INDICARD TEST
| Applicant | Litmus Concepts, Inc., Front Royal VA, US |
| Decision | Substantially Equivalent, Jun 19, 1997 |
| Received | Oct 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964015
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.