510(k) K071801 ยท JIX Calibrator, Multi-Analyte Mixture
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jul 20, 2007 |
| Received | Jul 2, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071801
| 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 |
| Sep 10, 2019 | Ortho-Clinical Diagnostics VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support 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 844 5207
Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration Terminated |
CGZ | None listed |
| Jul 11, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products Cl- Slides, Product Code 684 4471
Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.