K101037 is an FDA 510(k) clearance for the EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017. 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 May 23, 2011, 404 days after receiving the submission on April 14, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K101037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2010 |
| Decision Date | May 23, 2011 |
| Days to Decision | 404 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LFR — Glucose Dehydrogenase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |