K-number	K060489
Device name	DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
Applicant	Dade Behring, Inc.
Product code	JOZ
Device class	Class II
Decision date	Jul 21, 2006
Decision	Substantially Equivalent
Regulation	864.5700

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View the full FDA submission: accessdata.fda.gov

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DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS

Everything you need for a 510(k) submission. Nothing you don't.