510(k) K130628 ยท JIT Calibrator, Secondary
PATHFAST CK-MB-II CALIBRATORS
| Applicant | Mitsubishi Chemical Medience Corporation, Bethesda MD, US |
| Decision | Substantially Equivalent, Oct 4, 2013 |
| Received | Mar 8, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130628
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.