510(k) K903194 ยท GTZ Antisera, All Groups, Streptococcus Spp.
REDITEST STREP A TEST KIT
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 22, 1990 |
| Received | Jul 19, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903194
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.