K-number	K081719
Device name	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
Applicant	Stanbio Laboratory
Product code	GKR
Device class	Class II
Decision date	Jul 18, 2008
Decision	Substantially Equivalent
Regulation	864.5620

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View the full FDA submission: accessdata.fda.gov

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STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM

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