510(k) K040157 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS C-PEPTIDE CALCHECK
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 25, 2004 |
| Received | Jan 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040157
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.