510(k) K083680 ยท CEM Electrode, Ion Specific, Potassium
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 27, 2009 |
| Received | Dec 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083680
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596,
Product Usage:
For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure po Terminated |
CEM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.