510(k) K961191 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
COLISCREEN
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Jun 17, 1996 |
| Received | Mar 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961191
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.