The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Tysonbio Md100 Blood Glucse Monitoring ,tysonbio Md100 Pro Blood Glucise Monitoring System.
| Device ID | K112916 |
| 510k Number | K112916 |
| Device Name: | TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE 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 |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2012-08-21 |
| Summary: | summary |