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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 K943710
Device Name VERDICT COCAINE
Applicant
Editek, Inc.
1238 Anthony Rd.
Box 908
Burlington,  NC  27215
Applicant Contact CAROLE GOLDEN
Correspondent
Editek, Inc.
1238 Anthony Rd.
Box 908
Burlington,  NC  27215
Correspondent Contact CAROLE GOLDEN
Regulation Number862.3250
Classification Product Code
DIO  
Date Received08/01/1994
Decision Date 11/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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