510(k) K020129 ยท JIX Calibrator, Multi-Analyte Mixture
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
| Applicant | Phoenix Diagnostics, Inc., Natick MA, US |
| Decision | Substantially Equivalent, Feb 1, 2002 |
| Received | Jan 14, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020129
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.