510(k) K000042 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS B-CROSSLAPS CALCHECK
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 17, 2000 |
| Received | Jan 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000042
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.