The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Eps Easy Pain Supreme Self Monitoring Blood Glucose System.
| Device ID | K043245 |
| 510k Number | K043245 |
| Device Name: | EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | EPS BIO TECHNOLOGY CORP. 3892 SOUTH AMERICA WEST TRAIL Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich EPS BIO TECHNOLOGY CORP. 3892 SOUTH AMERICA WEST TRAIL Flagstaff, AZ 86001 |
| Product Code | CGA |
| 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 | 2004-11-23 |
| Decision Date | 2005-04-29 |
| Summary: | summary |