K-number	K012701
Device name	ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
Applicant	Accumetrics, Inc.
Product code	JOZ
Device class	Class II
Decision date	Jun 12, 2002
Decision	Substantially Equivalent
Regulation	864.5700

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ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)

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