The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Em44 Self Monitoring Blood Glucose System, Em44 Pro Self Monitoring Blood Glucose System.
| Device ID | K112272 |
| 510k Number | K112272 |
| Device Name: | EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO 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, Hsinchu, TW 30077 |
| Contact | Yc Lei |
| Correspondent | Yc Lei EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, Hsinchu, TW 30077 |
| Product Code | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-08 |
| Decision Date | 2011-09-07 |