510(k) K964315 ยท JWX Kit, Screening, Staphylococcus Aureus
REMEL STAPH LATEX KIT
| Applicant | Remel, L.P., Augusta GA, US |
| Decision | Substantially Equivalent, Feb 7, 1997 |
| Received | Oct 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964315
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.