510(k) K090939 ยท DKB Calibrators, Drug Mixture
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 18, 2009 |
| Received | Apr 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090939
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.