K-number	K192299
Device name	LZI Cotinine II Enzyme Immunoassay
Applicant	Lin-Zhi International, Inc.
Product code	MKU
Device class	Class I
Decision date	Nov 21, 2019
Decision	Substantially Equivalent
Regulation	862.3220

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View the full FDA submission: accessdata.fda.gov

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LZI Cotinine II Enzyme Immunoassay

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