The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Easyplus Mini R2n Self Monitoring Glucose Test System.
| Device ID | K081796 |
| 510k Number | K081796 |
| Device Name: | EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | EPS BIO TECHNOLOGY CORP. 2 F,NO. 49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City, TW 30071 |
| Contact | Y.c. Lei |
| Correspondent | Y.c. Lei EPS BIO TECHNOLOGY CORP. 2 F,NO. 49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City, TW 30071 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-25 |
| Decision Date | 2009-01-23 |
| Summary: | summary |