QStat Cartridge— 510(k) K213917

Substantially Equivalent

Hemosonics, LLC

FDA 510(k) clearance K213917 for QStat Cartridge, Substantially Equivalent on 2022-11-29. Applicant: Hemosonics, LLC.

Clearance details

Applicant: Hemosonics, LLC
Product code: Code QFR
Advisory panel: Hematology
Date received: 2021-12-15
Decision date: 2022-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

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