510(k) K093732 ยท JIX Calibrator, Multi-Analyte Mixture
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 22, 2010 |
| Received | Dec 4, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K093732
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2015 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.