510(k) K110061 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 21, 2011 |
| Received | Jan 10, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K110061
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.