K-number	K921681
Device name	CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
Applicant	Isolab, Inc.
Product code	GGM
Device class	Class II
Decision date	Nov 17, 1992
Decision	Substantially Equivalent
Regulation	864.8625

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View the full FDA submission: accessdata.fda.gov

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CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL

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