510(k) K033921 ยท JIF Enzymatic Method, Ammonia
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
| Applicant | Diagnostic Chemicals , Ltd., Charlottetown, P.E., CA |
| Decision | Substantially Equivalent, Mar 10, 2004 |
| Received | Dec 18, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033921
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2017 | Sekisui Diagnostics P.E.I. Inc. Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10
For the IN VITRO quantitative measurement of ammonia concentration in plasma Terminated |
JIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.