K-number	K062957
Device name	FASTPACK TOTAL PSA METHOD VERIFICATION KIT
Applicant	Qualigen, Inc.
Product code	JJX
Device class	Class I
Decision date	Apr 2, 2007
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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FASTPACK TOTAL PSA METHOD VERIFICATION KIT

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