510(k) K896109 ยท GTZ Antisera, All Groups, Streptococcus Spp.
IMMUNOCARD STREP A TEST
| Applicant | Disease Detection International, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 29, 1989 |
| Received | Oct 23, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896109
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.