TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K123087

Substantially Equivalent

Tyson Bioresearch, Inc.

FDA 510(k) clearance K123087 for TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2013-06-18. Applicant: Tyson Bioresearch, Inc..

Clearance details

Applicant: Tyson Bioresearch, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2012-10-01
Decision date: 2013-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Chun-Nan, Miao-Li County, TW

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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, 2020-01-01 through 2026-04-23. 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.