K-number	K011337
Device name	ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
Applicant	Accumetrics, Inc.
Product code	JOZ
Device class	Class II
Decision date	Oct 16, 2001
Decision	Substantially Equivalent
Regulation	864.5700

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ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)

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