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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gas chromatography, methamphetamine
510(k) Number K201442
Device Name Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
Applicant
Diatron Group
12601 N.W. 115th Avenue, Suite A113
Medley,  FL  33178
Applicant Contact Frank Matuszak
Correspondent
Ammirati Regulatory Consulting
575 Shirlynn Court
Los Altos,  CA  94022
Correspondent Contact Erika Ammirati
Regulation Number862.3610
Classification Product Code
LAF  
Date Received06/01/2020
Decision Date 07/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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