510(k) K981806 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
ALKP
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Jun 22, 1998 |
| Received | May 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981806
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2011 | Abbott Laboratories, Inc Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31.
Used for the quantitation of alkaline phosphatase in human serum or plasma. Terminated |
CJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.