510(k) K854150 ยท GTZ Antisera, All Groups, Streptococcus Spp.
PHADIRECT STREP A TEST
| Applicant | Pharmacia, Inc., Piscataway NJ, US |
| Decision | Substantially Equivalent, Oct 23, 1985 |
| Received | Oct 11, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854150
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.