510(k) K071216 ยท JFY Enzymatic Method, Creatinine
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 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 K071216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721 Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.