510(k) K972182 ยท MJZ Kit, Direct Antigen, Positive Control
ABBOTT STREP A CONTROLS
| Applicant | Abbott Diagnostics, Abbott Park IL, US |
| Decision | Substantially Equivalent, Aug 13, 1997 |
| Received | May 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972182
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.