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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 K994403
Device Name INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
Applicant
Alfa Scientific Designs, Inc.
11494 Sorrento Valley Rd.,
Suite F/M
San Diego,  CA  92121
Applicant Contact NAISHU WANG
Correspondent
Alfa Scientific Designs, Inc.
11494 Sorrento Valley Rd.,
Suite F/M
San Diego,  CA  92121
Correspondent Contact NAISHU WANG
Regulation Number862.3250
Classification Product Code
DIO  
Date Received12/28/1999
Decision Date 08/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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