RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device— 510(k) K221062

Substantially Equivalent

Bionime Corporation

FDA 510(k) clearance K221062 for RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device, Substantially Equivalent on 2022-09-26. Applicant: Bionime Corporation.

Clearance details

Applicant: Bionime Corporation
Product code: 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

Download summary PDF View on FDA.gov ↗

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.