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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 K080635
Device Name MEDTOXSCAN
Applicant
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact PHILLIP HARTZOG
Correspondent
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact PHILLIP HARTZOG
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JJQ   JXM   LCM   LDJ  
Date Received03/06/2008
Decision Date 02/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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