510(k) K970832 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
PYR SWAB
| Applicant | Remel, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Apr 24, 1997 |
| Received | Mar 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970832
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.