510(k) K041051 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
RAICHEM BUN RATE REAGENT (LIQUID)
| Applicant | Hemagen Diagnostics, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Jun 30, 2004 |
| Received | Apr 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041051
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.