The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Tyson Bio Ht100 Blood Glucose Monitoring System, Tyson Bio Ht100-b Blood Glucose Monitoring System.
| Device ID | K170079 |
| 510k Number | K170079 |
| Device Name: | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TYSON BIORESEARCH, INC. 5F, NO. 22, KE E. ROAD III SCIENCE-BASED INDUSTRIAL PARK Chu-nan, Miao-li County, TW 350 |
| Contact | Wen-hai Tsai |
| Correspondent | Feng-yu Lee IVDD REGULATORY CONSULTANT 29222 Rancho Viejo Rd, Suite 218 San Jan Capistrano, CA 92675 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-10 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719869702371 | K170079 | 000 |
| 14719869703016 | K170079 | 000 |
| 04719869702951 | K170079 | 000 |
| 14719869702002 | K170079 | 000 |
| 04719869701992 | K170079 | 000 |
| 14719869701982 | K170079 | 000 |
| 14719869701975 | K170079 | 000 |
| 14719869704181 | K170079 | 000 |
| 14719869704174 | K170079 | 000 |
| 14719869704167 | K170079 | 000 |
| 14719869703306 | K170079 | 000 |
| 14719869703221 | K170079 | 000 |
| 14719869703030 | K170079 | 000 |
| 14719869701791 | K170079 | 000 |
| 04719869702364 | K170079 | 000 |
| 04719869702357 | K170079 | 000 |
| 24719869702344 | K170079 | 000 |
| 24719869702337 | K170079 | 000 |
| 04719869702326 | K170079 | 000 |
| 04719869701961 | K170079 | 000 |
| 04719869701954 | K170079 | 000 |
| 04719869701947 | K170079 | 000 |
| 04719869701930 | K170079 | 000 |
| 24719869701835 | K170079 | 000 |
| 24719869701828 | K170079 | 000 |
| 04719869705396 | K170079 | 000 |