510(k) K100437 ยท NBW System, Test, Blood Glucose, Over The Counter
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
| Applicant | Bestgen Biotech Corp., Jhonghe City, Taipei County, TW |
| Decision | Substantially Equivalent, Jan 12, 2012 |
| Received | Feb 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100437
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.