K-number	K192433
Device name	LZI Methadone II Enzyme Immunoassay
Applicant	Lin-Zhi International, Inc.
Product code	DJR
Device class	Class II
Decision date	Oct 4, 2019
Decision	Substantially Equivalent
Regulation	862.3620

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View the full FDA submission: accessdata.fda.gov

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LZI Methadone II Enzyme Immunoassay

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