510(k) K060650 ยท LCP Assay, Glycosylated Hemoglobin
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Apr 6, 2006 |
| Received | Mar 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060650
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.