510(k) K922345 ยท GTZ Antisera, All Groups, Streptococcus Spp.
TESTPACK PLUS STREP A
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jul 16, 1992 |
| Received | May 19, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922345
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.