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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 K990325
Device Name QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
Applicant
Syntron Bioresearch, Inc.
1420 Los Angeles Ave. Suite 201
Simi Valley,  CA  93065
Applicant Contact CLEVE W LAIRD
Correspondent
Syntron Bioresearch, Inc.
1420 Los Angeles Ave. Suite 201
Simi Valley,  CA  93065
Correspondent Contact CLEVE W LAIRD
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   JXM  
LCM   LDJ  
Date Received02/02/1999
Decision Date 06/24/1999
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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