510(k) K001769 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Jun 21, 2000 |
| Received | Jun 12, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001769
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.