The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Diachex Blood Glucose Monitoring System.
| Device ID | K062829 |
| 510k Number | K062829 |
| Device Name: | DIACHEX BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TYSON BIORESEARCH, INC. 5 F., # 22, KE TUNG RD., SCIENCE BASED INDUSTRIAL PARK Chun-nan, Miao-li County, TW 350 |
| Contact | Wen-hai Tsai |
| Correspondent | Wen-hai Tsai TYSON BIORESEARCH, INC. 5 F., # 22, KE TUNG RD., 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 | 2006-09-20 |
| Decision Date | 2006-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24719869700661 | K062829 | 000 |