510(k) K971349 ยท GTY Antigens, All Groups, Streptococcus Spp.
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Jul 7, 1997 |
| Received | Apr 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971349
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.