The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Tyson Bio Ht100-a Blood Glucose Monitoring System; Tyson Bio Ht100-c Blood Glucose Monitoring System.
| Device ID | K182047 |
| 510k Number | K182047 |
| Device Name: | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Tyson Bioresearch, Inc. 5F., No. 16, 18, 20, 22, Kedong 3rd Rd. Zhunan Township, TW 35053 |
| Contact | Vance Chang |
| Correspondent | Feng- Yu Lee Dynamic Biotech Inc. Dba IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-31 |
| Decision Date | 2018-11-29 |
| Summary: | summary |