510(k) K061838 ยท JIX Calibrator, Multi-Analyte Mixture
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 21, 2006 |
| Received | Jun 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Chemistry 1 Calibrator
The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (G Terminated |
JIX | None listed |
| Sep 30, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista CHEM 1 CAL, lot 3GM081.
The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid Terminated |
JIX | None listed |
| Feb 26, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001
The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Cr Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.