510(k) K062972 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 13, 2006 |
| Received | Sep 29, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062972
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.