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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
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