510(k) K043460 ยท JIX Calibrator, Multi-Analyte Mixture
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Jan 31, 2005 |
| Received | Dec 15, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K043460
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2017 | Beckman Coulter Inc. Lyophilized Chemistry Calibrator Level 1
Product Usage:
Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzer Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.