The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Eg V1 (bl) Self Monitoring Glucose Test System Model: Eps10017.
| Device ID | K101037 |
| 510k Number | K101037 |
| Device Name: | EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, TW 30077 |
| Contact | Yc Lei |
| Correspondent | Yc Lei EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, TW 30077 |
| Product Code | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2011-05-23 |
| Summary: | summary |