510(k) K070200 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
TDM CONTROL SET, MODEL CAT# 04521536
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 19, 2007 |
| Received | Jan 22, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070200
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.