510(k) K895103 ยท GTZ Antisera, All Groups, Streptococcus Spp.
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 29, 1989 |
| Received | Aug 15, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895103
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.