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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 K033094
Device Name ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
Applicant
Lin-Zhi International, Inc.
687 N. Pastoria Ave.
Synnyvale,  CA  94085
Applicant Contact CHENG-I LIN
Correspondent
Lin-Zhi International, Inc.
687 N. Pastoria Ave.
Synnyvale,  CA  94085
Correspondent Contact CHENG-I LIN
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DLJ   LAS  
Date Received09/29/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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