510(k) K093611 ยท KHS Enzymatic, Carbon-Dioxide
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Apr 15, 2010 |
| Received | Nov 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093611
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.