The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Ez Scan Plus Blood Glucose Monitoring System.
| Device ID | K072441 |
| 510k Number | K072441 |
| Device Name: | EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TYSON BIORESEARCH, INC. 5F, #22, KE E. ROAD, III SCIENCE-BASED INDUSTRIAL PARK Chu-nan, TW 350 |
| Contact | Wen-hai Tsai |
| Correspondent | Wen-hai Tsai TYSON BIORESEARCH, INC. 5F, #22, KE E. ROAD, III SCIENCE-BASED INDUSTRIAL PARK Chu-nan, TW 350 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-30 |
| Decision Date | 2008-03-25 |
| Summary: | summary |