510(k) K020369 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS ANTI-TG CALCHECK
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 6, 2002 |
| Received | Feb 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020369
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.