The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Tysonbio Ac500, Ac800 Blood Glucose Monitoring System, Tysonbio Ac500 Ac800 Pro Blood Glucose Monitoring System.
| Device ID | K123087 |
| 510k Number | K123087 |
| Device Name: | TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TYSON BIORESEARCH, INC. 5 F., # 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. 5 F., # 22, KE E. ROAD III SCIENCE BASED INDUSTRIAL PARK Chun-nan, Miao-li County, TW 350 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719869703498 | K123087 | 000 |
| 14719869703054 | K123087 | 000 |
| 14719869703108 | K123087 | 000 |
| 14719869703115 | K123087 | 000 |
| 14719869703122 | K123087 | 000 |
| 04719869703132 | K123087 | 000 |
| 14719869703146 | K123087 | 000 |
| 14719869703153 | K123087 | 000 |
| 14719869703160 | K123087 | 000 |
| 14719869703481 | K123087 | 000 |
| 04719869702968 | K123087 | 000 |