510(k) K955141 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
OSOM HCG COMBO TEST
| Applicant | Wyntek Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 6, 1995 |
| Received | Nov 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955141
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.