The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Tyson Bio Hs100 Blood Glucose Monitoring System, Tyson Bio Hs100-b Blood Glucose Monitoring System.
| Device ID | K182046 |
| 510k Number | K182046 |
| Device Name: | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B 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 | 2018-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719869702941 | K182046 | 000 |
| 14719869702095 | K182046 | 000 |
| 14719869702798 | K182046 | 000 |
| 14719869702811 | K182046 | 000 |
| 04719869702852 | K182046 | 000 |
| 04719869702869 | K182046 | 000 |
| 04719869702456 | K182046 | 000 |
| 14719869702781 | K182046 | 000 |
| 14719869702804 | K182046 | 000 |
| 14719869702033 | K182046 | 000 |