510(k) K033185 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
COBAS INTEGRA ALP IFCC GEN.2
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 14, 2003 |
| Received | Oct 1, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033185
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.