The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Tysonbio Blood Glucose Monitoring System, Models Ac100 And Ac200.
| Device ID | K101543 |
| 510k Number | K101543 |
| Device Name: | TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TYSON BIORESEARCH, INC. 5F, #22, KE E. ROAD, III SCIENCE-BASED INDUSTRIAL PARK Chun-nan, Miao-li County, TW 350 |
| Contact | Wen-hai Tsai |
| Correspondent | Wen-hai Tsai TYSON BIORESEARCH, INC. 5F, #22, KE E. ROAD, III SCIENCE-BASED INDUSTRIAL PARK Chun-nan, Miao-li County, TW 350 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2011-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719869702395 | K101543 | 000 |
| 04719869701503 | K101543 | 000 |
| 04719869701497 | K101543 | 000 |
| 04719869701473 | K101543 | 000 |