510(k) K961423 ยท GTZ Antisera, All Groups, Streptococcus Spp.
OSOM STREP A TEST
| Applicant | Wyntek Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 11, 1996 |
| Received | Apr 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961423
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.