510(k) K113314 ยท LFR Glucose Dehydrogenase, Glucose
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Hmd Biomedical, Inc., Xinpu Township, Hsinchu County, TW |
| Decision | Substantially Equivalent, Nov 9, 2012 |
| Received | Nov 9, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113314
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.