510(k) K062118 ยท CFR Hexokinase, Glucose
POINTE 360
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Jul 13, 2007 |
| Received | Jul 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062118
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.