510(k) K071215 ยท JFY Enzymatic Method, Creatinine
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 25, 2007 |
| Received | May 2, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071215
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.