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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 K033866
Device Name CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
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 Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DJG   DZK   LCM  
Date Received12/12/2003
Decision Date 04/07/2004
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
Predetermined Change
Control Plan Authorized		 No
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