510(k) K122323 ยท CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Aug 28, 2012 |
| Received | Aug 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2020 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma
Catalog Number Terminated |
CJO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.