510(k) K073157 ยท CEM Electrode, Ion Specific, Potassium
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 7, 2007 |
| Received | Nov 8, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073157
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2019 | Ortho-Clinical Diagnostics VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form. Terminated |
CEM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.