The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Easymax Self Monitoring Glucose Test System, Model # Eps08005.
| Device ID | K082121 |
| 510k Number | K082121 |
| Device Name: | EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| Subsequent Product Code | JJY |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-28 |
| Decision Date | 2008-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885017000355 | K082121 | 000 |
| 00885017000591 | K082121 | 000 |
| 10885017000550 | K082121 | 000 |
| 10885017000277 | K082121 | 000 |
| 00885017000010 | K082121 | 000 |