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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 K110239
Device Name LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
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 Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DLJ   LAS  
Date Received01/26/2011
Decision Date 06/23/2011
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
Predetermined Change
Control Plan Authorized		 No
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