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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K141205
Device Name LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
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 Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DLJ   LAS  
Date Received05/09/2014
Decision Date 02/13/2015
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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