510(k) K061923 ยท JIX Calibrator, Multi-Analyte Mixture
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 25, 2006 |
| Received | Jul 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061923
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012.
An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.