510(k) K834582 ยท GTZ Antisera, All Groups, Streptococcus Spp.
DETECT GROUP A STREP TEST
| Applicant | Difco Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 4, 1984 |
| Received | Dec 29, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834582
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.