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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, Cocaine And Cocaine Metabolites
510(k) Number K010239
Device Name COCAINE DIPSTICK TEST, MODEL D747-A
Applicant
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Applicant Contact DINDO CARRILLO
Correspondent
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Correspondent Contact DINDO CARRILLO
Regulation Number862.3250
Classification Product Code
DIO  
Date Received01/25/2001
Decision Date 06/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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