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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Tricyclic Antidepressant Drugs
510(k) Number K022693
Device Name INSTANT-VIEW TCA URINE TEST
Applicant
Alfa Scientific Designs, Inc.
12330 Stowe Dr.
Poway,  CA  92064
Applicant Contact NAISHU WANG
Correspondent
Alfa Scientific Designs, Inc.
12330 Stowe Dr.
Poway,  CA  92064
Correspondent Contact NAISHU WANG
Regulation Number862.3910
Classification Product Code
MLK  
Date Received08/13/2002
Decision Date 12/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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