K-number	K101388
Device name	FASTPACK TESTO IMMUNOASSAY
Applicant	Qualigen, Inc.
Product code	CDZ
Device class	Class I
Decision date	Feb 18, 2011
Decision	Substantially Equivalent
Regulation	862.1680

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View the full FDA submission: accessdata.fda.gov

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FASTPACK TESTO IMMUNOASSAY

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