K-number	K915344
Device name	HEMOCHRON ONESTEP APTT TEST
Applicant	International Technidyne Corp.
Product code	GFO
Device class	Class II
Decision date	Feb 11, 1992
Decision	Substantially Equivalent
Regulation	864.7925

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View the full FDA submission: accessdata.fda.gov

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HEMOCHRON ONESTEP APTT TEST

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