510(k) K103044 ยท NBW System, Test, Blood Glucose, Over The Counter
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
| Applicant | Bestgen Biotech Corp., Jung-He, Taipei County, TW |
| Decision | Substantially Equivalent, Feb 10, 2012 |
| Received | Oct 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103044
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.