510(k) K112528 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS T4 CALCHECK 5
| Applicant | Roche Diagnostics Corporation, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 18, 2011 |
| Received | Aug 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112528
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.