510(k) K103531 ยท CFR Hexokinase, Glucose
PRESTIGE 24I; BIOLIS 24I; MGC 240
| Applicant | Tokyo Boeki Medisys, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Dec 1, 2011 |
| Received | Dec 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103531
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.