510(k) K030035 ยท JFY Enzymatic Method, Creatinine
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
| Applicant | Diametrics Medical, Inc., Roseville MN, US |
| Decision | Substantially Equivalent, Jun 25, 2003 |
| Received | Jan 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030035
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.