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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, cannabinoids
510(k) Number K141320
Device Name LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
Applicant
Lin-Zhi International, Inc.
670 ALMANOR AVE.
SUNNYVALE,  CA  94085
Applicant Contact BERNIECE LIN
Correspondent
Lin-Zhi International, Inc.
670 ALMANOR AVE.
SUNNYVALE,  CA  94085
Correspondent Contact BERNICE LIN
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DLJ   LAS  
Date Received05/20/2014
Decision Date 05/28/2015
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
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