K-number	K013152
Device name	ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
Applicant	Elan Holdings, Inc.
Product code	LBS
Device class	Class I
Decision date	Nov 9, 2001
Decision	Substantially Equivalent
Regulation	862.1475

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ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

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