510(k) K061879 ยท CFR Hexokinase, Glucose
SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM
| Applicant | Hemodiagnostica, LLC, Johns Island SC, US |
| Decision | Substantially Equivalent, Dec 15, 2006 |
| Received | Jul 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061879
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.