K232416 is an FDA 510(k) clearance for the AUTION EYE AI-4510 Urine Particle Analysis System. This device is classified as a Counter, Urine Particle (Class II - Special Controls, product code LKM).
Submitted by Arkray, Inc. (Kyoto, JP). The FDA issued a Cleared decision on May 3, 2024, 266 days after receiving the submission on August 11, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K232416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2023 |
| Decision Date | May 03, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LKM - Counter, Urine Particle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |