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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 K033566
Device Name MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
Applicant
Rapid Diagnostics, Inc.
9418 Lasaine Ave.
Northridge,  CA  91325
Applicant Contact ROBIN J HELLEN
Correspondent
Rapid Diagnostics, Inc.
9418 Lasaine Ave.
Northridge,  CA  91325
Correspondent Contact ROBIN J HELLEN
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   LCM   LDJ  
Date Received11/12/2003
Decision Date 05/17/2004
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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