RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device— 510(k) K221062
Substantially EquivalentBionime 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. Device class: 2.
Clearance details
- Applicant
- Bionime Corporation
- Product code
- Code QRL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
Recent devices under product code QRL
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view all- K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel
- K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel
- K190564 — Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
- K173638 — Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
- K173139 — Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
Adverse events under product code QRL
product code QRL- Other
- 1
- Total
- 1
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.