510(k) K023876 ยท JIX Calibrator, Multi-Analyte Mixture
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 10, 2002 |
| Received | Nov 21, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023876
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204
VITROS Mg Slides quantitatively measure magnesium (Mg) conc Terminated |
JGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.