K-number	K974901
Device name	HYBRID CAPTURE SYSTEM CMV DNA ASSAY
Applicant	Digene Corp.
Product code	LJO
Device class	Class II
Decision date	Sep 29, 1998
Decision	Substantially Equivalent
Regulation	866.3175

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View the full FDA submission: accessdata.fda.gov

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HYBRID CAPTURE SYSTEM CMV DNA ASSAY

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