510(k) K061139 ยท JIT Calibrator, Secondary
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 6, 2006 |
| Received | Apr 24, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K061139
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.