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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 K131652
Device Name LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
Applicant
Lin-Zhi International, Inc.
670 Almanor Ave.
Sunnyvale,  CA  94085
Applicant Contact BERNICE LIN
Correspondent
Lin-Zhi International, Inc.
670 Almanor Ave.
Sunnyvale,  CA  94085
Correspondent Contact BERNICE LIN
Regulation Number862.3610
Classification Product Code
LAF  
Subsequent Product Codes
DLJ   LAS  
Date Received06/05/2013
Decision Date 03/21/2014
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
Predetermined Change
Control Plan Authorized		 No
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