510(k) K133816 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 24, 2014 |
| Received | Dec 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133816
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.