510(k) K981918 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
UREA
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Jul 28, 1998 |
| Received | Jun 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981918
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2011 | Abbott Laboratories, Inc Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine. Terminated |
CDQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.