510(k) K002694 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
| Applicant | Diagnostic Chemicals , Ltd., Charlottetown, P.E., CA |
| Decision | Substantially Equivalent, Sep 15, 2000 |
| Received | Aug 29, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002694
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.