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. Device class: 2.

Clearance details

Applicant: Hemosonics, LLC
Product code: Code QFR
Device class: Class 2
Regulation: 21 CFR 864.5430
Advisory panel: Hematology
Date received: 2021-12-15
Decision date: 2022-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hemosonics, LLC

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Data sourced from openFDA. This site is unofficial and independent of the FDA.