510(k) K971309 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
UREA
| Applicant | Derma Media Lab., Inc., Santa Fe Springs CA, US |
| Decision | Substantially Equivalent, Aug 1, 1997 |
| Received | Apr 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971309
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.