TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200— 510(k) K101543
Substantially EquivalentTyson Bioresearch, Inc.
FDA 510(k) clearance K101543 for TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200, Substantially Equivalent on 2011-08-30. Applicant: Tyson Bioresearch, Inc.. Device class: 2.
Clearance details
- Applicant
- Tyson Bioresearch, Inc.
- Product code
- Code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chu-Nan, Miao-Li County, TW
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More clearances from Tyson Bioresearch, Inc.
view all- K182046 — Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
- K182047 — Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
- K170079 — Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
- K123087 — TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
- K112916 — TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM
Adverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.