510(k) K062334 ยท JIX Calibrator, Multi-Analyte Mixture
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 22, 2006 |
| Received | Aug 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062334
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista CHEM 3 calibrator
is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.