K252580 is an FDA 510(k) clearance for the iQ200 Series. This device is classified as a Counter, Urine Particle (Class II - Special Controls, product code LKM).
Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on September 10, 2025, 26 days after receiving the submission on August 15, 2025.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K252580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2025 |
| Decision Date | September 10, 2025 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | LKM — Counter, Urine Particle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |