510(k) K110613 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS PROLACTIN II CALCHECK 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 12, 2011 |
| Received | Mar 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110613
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.