510(k) K897083 ยท GTZ Antisera, All Groups, Streptococcus Spp.
VENTRESIGN STREP A TEST
| Applicant | Ventrex Laboratories, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Jan 22, 1990 |
| Received | Dec 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897083
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.