510(k) K842827 ยท GTZ Antisera, All Groups, Streptococcus Spp.
STREPTEX DIRECT A ZL14
| Applicant | Wellcome Diagnostics, Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 16, 1984 |
| Received | Jul 20, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842827
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.