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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 K040092
Device Name AMEDITECH IMMU TEST DRUG SCREEN PANEL
Applicant
AMEDITECH, INC.
10340 CAMINO SANTA FE
SUITES F-G
SAN DIEGO,  CA  92121
Applicant Contact JOHN WU
Correspondent
AMEDITECH, INC.
10340 CAMINO SANTA FE
SUITES F-G
SAN DIEGO,  CA  92121
Correspondent Contact JOHN WU
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJC   DJG   DKE   LCM  
Date Received01/16/2004
Decision Date 03/08/2004
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
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