Cleared Traditional

iQ200 System, iChemVELOCITY Automated Urine Chemistry System

K210127 · Beckman Coulter, Inc. · Hematology
Jul 2021
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K210127 is an FDA 510(k) clearance for the iQ200 System, iChemVELOCITY Automated Urine Chemistry System, 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 July 2, 2021, 164 days after receiving the submission on January 19, 2021. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K210127 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2021
Decision Date July 02, 2021
Days to Decision 164 days
Submission Type Traditional
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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