K-number	K061047
Device name	HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
Applicant	Hemocue AB
Product code	GKR
Device class	Class II
Decision date	Jun 8, 2006
Decision	Substantially Equivalent
Regulation	864.5620

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View the full FDA submission: accessdata.fda.gov

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HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801

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