510(k) K053059 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 28, 2005 |
| Received | Oct 31, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053059
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.