K-number	K021385
Device name	ATAC PAK BUN REAGENT
Applicant	Elan Diagnostics
Product code	CDQ
Device class	Class II
Decision date	Jul 12, 2002
Decision	Substantially Equivalent
Regulation	862.1770

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View the full FDA submission: accessdata.fda.gov

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ATAC PAK BUN REAGENT

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