510(k) K980057 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
CARESIDE BUN
| Applicant | Exigent Diagnostics, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Feb 5, 1998 |
| Received | Jan 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980057
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.