K-number	K180835
Device name	SEKURE Acetaminophen L3K Assay
Applicant	Sekisui Diagnostics P.E.I., Inc.
Product code	LDP
Device class	Class II
Decision date	Feb 8, 2019
Decision	Substantially Equivalent
Regulation	862.3030

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Source

View the full FDA submission: accessdata.fda.gov

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SEKURE Acetaminophen L3K Assay

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