510(k) K141928 ยท DKB Calibrators, Drug Mixture
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 25, 2014 |
| Received | Jul 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141928
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.