AUTION EYE AI-4510 Urine Particle Analysis System
510(k)K232416HematologyLKM
Arkray Inc. is listed for AUTION EYE AI-4510 Urine Particle Analysis System (K232416). The FDA list gives May 3, 2024 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is LKM. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232416
- Date of final decision
- May 3, 2024
- Company on the FDA list
- Arkray Inc.
- Lead panel
- Hematology
- Primary product code
- LKM
- openFDA device name for the code
- Counter, Urine Particle
- Device class
- 2
- Regulation number
- 864.5200
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary