K-number	K011972
Device name	DIRECT BILIRUBIN REAGENT
Applicant	Intersect Systems, Inc.
Product code	CIG
Device class	Class II
Decision date	Aug 27, 2001
Decision	Substantially Equivalent
Regulation	862.1110

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View the full FDA submission: accessdata.fda.gov

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DIRECT BILIRUBIN REAGENT

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