K-number	K990234
Device name	QUALISYS PSA IMMUNOASSAY
Applicant	Qualisys Diagnostics, Inc.
Product code	LTJ
Device class	Class II
Decision date	Jul 8, 1999
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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QUALISYS PSA IMMUNOASSAY

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