510(k) K103612 ยท JIX Calibrator, Multi-Analyte Mixture
DIMENSION VISA ENZ 2 CAL
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 25, 2011 |
| Received | Dec 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2016 | Siemens Healthcare Diagnostics, Inc. The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. F Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.