The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Easy Step And Diachex+ Pro Blood Glucose Monitoring Systems.
| Device ID | K090629 |
| 510k Number | K090629 |
| Device Name: | EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TYSON BIORESEARCH, INC. 5F, #22, KE E. ROAD, III SCIENCE-BASED INDUSTRIAL PARK Chun-nan, Miao-li County, TW 350 |
| Contact | Wen-hai Tsai |
| Correspondent | Wen-hai Tsai TYSON BIORESEARCH, INC. 5F, #22, KE E. ROAD, III SCIENCE-BASED INDUSTRIAL PARK Chun-nan, Miao-li County, TW 350 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-09 |
| Decision Date | 2009-06-04 |
| Summary: | summary |