510(k) K012649 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
RAICHEM BUN RATE REAGENT
| Applicant | Hemagen Diagnostics, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Oct 15, 2001 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012649
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.