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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
510(k) Number K010079
Device Name INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP 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 Number862.3640
Classification Product Code
DOE  
Date Received01/10/2001
Decision Date 05/29/2001
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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