510(k) K912868 ยท GTZ Antisera, All Groups, Streptococcus Spp.
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 7, 1991 |
| Received | Jun 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912868
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.