K252580
- 510(k) number
- K252580
- Device name
- iQ200 Series
- Applicant
- Beckman Coulter, Inc. FL · US
- Product code
- LKM — Counter, Urine Particle
- Decision date
- 2025-09-10
- Date received
- 2025-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252580.pdf
Official FDA record: K252580
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.