510(k) K962296 ยท GTZ Antisera, All Groups, Streptococcus Spp.
STREPTOLEX-STAT
| Applicant | Unipath , Ltd., Beverly MA, US |
| Decision | Substantially Equivalent, Dec 16, 1996 |
| Received | Jun 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962296
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.