K-number	K110726
Device name	ROCHE ACETAMINOPHEN ASSAY
Applicant	Roche Diagnostics
Product code	LDP
Device class	Class II
Decision date	Dec 23, 2011
Decision	Substantially Equivalent
Regulation	862.3030

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View the full FDA submission: accessdata.fda.gov

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ROCHE ACETAMINOPHEN ASSAY

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