K133389 is an FDA 510(k) clearance for the EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Eps Bio Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on April 15, 2014, 161 days after receiving the submission on November 5, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K133389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2013 |
| Decision Date | April 15, 2014 |
| Days to Decision | 161 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |