K221062

Substantially Equivalent

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device

Applicant: Bionime Corporation
Product code: QRL
Advisory panel: General, Plastic Surgery
Date received: 2022-04-11
Decision date: 2022-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

Adverse events under product code QRL

product code QRL

Other: 1
Total: 1

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.