Cleared Special

iQ200 Series

K252580 · Beckman Coulter, Inc. · Hematology
Sep 2025
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K252580 is an FDA 510(k) clearance for the iQ200 Series, 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 review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K252580 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LKM — Counter, Urine Particle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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