510(k) K011586 ยท GAA Needle, Aspiration And Injection, Disposable
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
| Applicant | Diametrics Medical, Inc., Roseville MN, US |
| Decision | Substantially Equivalent, Nov 16, 2001 |
| Received | May 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011586
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.