K-number	K052301
Device name	FASTPACK TSH IMMUNOASSAY
Applicant	Qualigen, Inc.
Product code	JLW
Device class	Class II
Decision date	Jan 4, 2006
Decision	Substantially Equivalent
Regulation	862.1690

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View the full FDA submission: accessdata.fda.gov

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FASTPACK TSH IMMUNOASSAY

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