K-number	K030003
Device name	ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
Applicant	Elan Diagnostics
Product code	CIG
Device class	Class II
Decision date	Sep 29, 2003
Decision	Substantially Equivalent
Regulation	862.1110

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View the full FDA submission: accessdata.fda.gov

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ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR

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