K-numberK170416
Device nameLZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
ApplicantLin-Zhi International, Inc.
Product codeDJR
Device classClass II
Decision dateJun 26, 2017
DecisionSubstantially Equivalent
Regulation862.3620
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