510(k) K072443 ยท CJY Azo Dye, Calcium
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 24, 2007 |
| Received | Aug 30, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072443
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.