The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Diachex+determine Blood Glucose Monitoring System, Diachex-infinity Blood Glucose Monitoring System.
| Device ID | K073492 |
| 510k Number | K073492 |
| Device Name: | DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-12 |
| Decision Date | 2008-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24719869701064 | K073492 | 000 |
| 24719869701057 | K073492 | 000 |
| 04719869701046 | K073492 | 000 |