510(k) K021385 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
ATAC PAK BUN REAGENT
| Applicant | Elan Diagnostics, Brea CA, US |
| Decision | Substantially Equivalent, Jul 12, 2002 |
| Received | May 2, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021385
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.