510(k) K023407 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
| Applicant | Elan Diagnostics, Brea CA, US |
| Decision | Substantially Equivalent, Feb 14, 2003 |
| Received | Oct 10, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023407
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.