510(k) K091861 ยท JGS Electrode, Ion Specific, Sodium
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 3, 2009 |
| Received | Jun 19, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091861
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.