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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K133710
Device Name LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE 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 Number862.3200
Classification Product Code
DKB  
Subsequent Product Code
DIF  
Date Received12/04/2013
Decision Date 02/21/2014
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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