510(k) K001015 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS THYROGLOBULIN CALCHECK
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 27, 2000 |
| Received | Mar 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001015
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.