K-number	K994419
Device name	FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
Applicant	Qualisys Diagnostics, Inc.
Product code	LTJ
Device class	Class II
Decision date	Jun 28, 2000
Decision	Substantially Equivalent
Regulation	866.6010

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FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

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