510(k) K061703 ยท JIX Calibrator, Multi-Analyte Mixture
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 2, 2006 |
| Received | Jun 16, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061703
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Chemistry 2 Calibrator, Catalog number KC120.
Used to calibrate Phosphate, Salicylate, and Triglycerides methods 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.