K-number	K201217
Device name	HemoCue Hb 301 System
Applicant	Hemocue AB
Product code	GKR
Device class	Class II
Decision date	Aug 4, 2020
Decision	Substantially Equivalent
Regulation	864.5620

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Source

View the full FDA submission: accessdata.fda.gov

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HemoCue Hb 301 System

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