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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 K053175
Device Name AMEDITECH DRUGSMARTCUP
Applicant
AMEDITECH, INC.
10340 CAMINO SANTA FE, SUITE F
SAN DIEGO,  CA  92121
Applicant Contact JOHN WU
Correspondent
AMEDITECH, INC.
10340 CAMINO SANTA FE, SUITE F
SAN DIEGO,  CA  92121
Correspondent Contact JOHN WU
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   LCM   LDJ   LFG  
Date Received11/14/2005
Decision Date 12/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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