Multi-Lancet Device 2, ReliOn Premier Lancing Device— 510(k) K221175
Substantially EquivalentArkray, Inc.
FDA 510(k) clearance K221175 for Multi-Lancet Device 2, ReliOn Premier Lancing Device, Substantially Equivalent on 2022-10-17. Applicant: Arkray, Inc.. Device class: 2.
Clearance details
- Applicant
- Arkray, Inc.
- 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
- Kyoto, JP
Recent devices under product code QRL
view allMore clearances from Arkray, Inc.
view all- K232416 — AUTION EYE AI-4510 Urine Particle Analysis System
- K193514 — AUTION MAX AX-4060 Urinalysis System
- K200788 — Assure Titanium Blood Glucose Monitoring System
- K160062 — AUTION ELEVEN Semi-Automated Urinalysis System
- K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
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.