K-number	K020575
Device name	ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
Applicant	Elan Diagnostics
Product code	MRR
Device class	Class I
Decision date	Apr 12, 2002
Decision	Substantially Equivalent
Regulation	862.1475

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Source

View the full FDA submission: accessdata.fda.gov

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ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS

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