510(k) K001310 ยท JFY Enzymatic Method, Creatinine
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 5, 2000 |
| Received | Apr 25, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001310
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.