510(k) K980043 ยท JFY Enzymatic Method, Creatinine
CARESIDE CREATININE
| Applicant | Exigent Diagnostics, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Mar 30, 1998 |
| Received | Jan 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980043
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.