510(k) K103836 ยท JIT Calibrator, Secondary
ENZYME II CALIBRATOR
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 16, 2011 |
| Received | Dec 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103836
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2017 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture
Product Usage:
Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c Terminated |
JIS | None listed |
| May 5, 2016 | Siemens Healthcare Diagnostics, Inc. The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension clinical chemistry system. For prescription use only. Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.