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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, cocaine and cocaine metabolites
510(k) Number K113139
Device Name LZI COCAINE METABOLITE HOMOGENEOUS 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 Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DLJ   LAS  
Date Received10/24/2011
Decision Date 11/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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