510(k) K121907 ยท CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Jul 23, 2012 |
| Received | Jun 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121907
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.