K113243 is an FDA 510(k) clearance for the EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM. This device is classified as a Glucose Dehydrogenase, Glucose (Class II - Special Controls, product code LFR).
Submitted by Eps Bio Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on March 28, 2012, 147 days after receiving the submission on November 2, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K113243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2011 |
| Decision Date | March 28, 2012 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LFR — Glucose Dehydrogenase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |