510(k) K042389 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 14, 2004 |
| Received | Sep 2, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042389
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.