510(k) K854278 ยท JWX Kit, Screening, Staphylococcus Aureus
NEG COMBO BREAKPOINT PANEL POS COMBO
| Applicant | American Micro Scan, Sacramento CA, US |
| Decision | Substantially Equivalent, Mar 4, 1986 |
| Received | Oct 24, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854278
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.