FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
K Number: K221062
·
Decision Sep 26, 2022
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
23
Applicant Total
21
Review Days
168
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Basic Information
- Device Name
- RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
- K Number
- K221062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionime Corporation
- Date Received
- April 11, 2022
- Decision Date
- September 26, 2022
- Product Code
- QRL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QRL), ordered by most recent decision date.
Lancing device (HH-XV-T)
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MICROLET®NEXT 2 Lancing Device
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Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)
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Verifine® Ease Lancing Device, Verifine® Lancing Device
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Other Clearances by Bionime Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Nov 4, 2024 | Substantially Equivalent |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Jan 19, 2024 | Substantially Equivalent |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | Jun 2, 2019 | Substantially Equivalent |
| 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 | Aug 17, 2018 | Substantially Equivalent |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | Jun 19, 2018 | Substantially Equivalent |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | Jul 6, 2017 | Substantially Equivalent |
| K161790 | iGlucose Blood Glucose Monitoring System | May 2, 2017 | Substantially Equivalent |
| K140210 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 | Aug 22, 2014 | Substantially Equivalent |
| K133003 | RIGHTEST CONTROL SOLUTION | Oct 24, 2013 | Substantially Equivalent |
| K123008 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN | Jan 25, 2013 | Substantially Equivalent |