510(k) K162020 ยท CGZ Electrode, Ion-Specific, Chloride
VITROS Chemistry Products Cl- Slides
| Applicant | Ortho Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Dec 16, 2016 |
| Received | Jul 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2019 | Ortho-Clinical Diagnostics VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form. Terminated |
CGZ | None listed |
| Jul 11, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products Cl- Slides, Product Code 684 4471
Product Usage:
VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitati Terminated |
CGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.