510(k) K112272 ยท LFR Glucose Dehydrogenase, Glucose
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
| Applicant | Eps Bio Technology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Sep 7, 2011 |
| Received | Aug 8, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112272
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.