510(k) K954000 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
ROCHE REAGENT FOR BUN
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Oct 25, 1995 |
| Received | Aug 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954000
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.