iQ200 System, iChemVELOCITY Automated Urine Chemistry System— 510(k) K210127

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K210127 for iQ200 System, iChemVELOCITY Automated Urine Chemistry System, Substantially Equivalent on 2021-07-02. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LKM
Advisory panel: Hematology
Date received: 2021-01-19
Decision date: 2021-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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