AUTION EYE AI-4510 Urine Particle Analysis System— 510(k) K232416
Substantially EquivalentArkray, Inc.
FDA 510(k) clearance K232416 for AUTION EYE AI-4510 Urine Particle Analysis System, Substantially Equivalent on 2024-05-03. Applicant: Arkray, Inc.. Device class: 2.
Clearance details
- Applicant
- Arkray, Inc.
- Product code
- Code LKM
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kyoto, JP
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