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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, Opiates
510(k) Number K063015
Device Name AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150
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 Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   JXN  
Date Received10/02/2006
Decision Date 12/20/2006
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
Recalls CDRH Recalls
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