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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 K060810
Device Name ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
Applicant
Ind Diagnostic, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Applicant Contact JASON PENG
Correspondent
Ind Diagnostic, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Correspondent Contact JASON PENG
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJG   LAF   LDJ  
Date Received03/24/2006
Decision Date 08/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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