The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Em50 Self Monitoring Blood Glucose System.
| Device ID | K113243 |
| 510k Number | K113243 |
| Device Name: | EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, TW 30077 |
| Contact | Cynthia Hung |
| Correspondent | Cynthia Hung 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 | 2011-11-02 |
| Decision Date | 2012-03-28 |