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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, Amphetamine
510(k) Number K102210
Device Name LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 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 Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DLJ   LAS  
Date Received08/05/2010
Decision Date 12/28/2010
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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