510(k) K992658 ยท GTY Antigens, All Groups, Streptococcus Spp.
OSOM ULTRA STREP A TEST, MODEL 147
| Applicant | Wyntek Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 18, 2000 |
| Received | Aug 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992658
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.