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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Vibrio Cholerae, All Varieties
510(k) Number K954995
Device Name QUIX RAPID CHOLERA STRIP TEST
Applicant
Guardian Scientific, Corp.
8990-E Rte. 108
Columbia,  MD  21045
Applicant Contact KATHRYN B POWERS
Correspondent
Guardian Scientific, Corp.
8990-E Rte. 108
Columbia,  MD  21045
Correspondent Contact KATHRYN B POWERS
Regulation Number866.3930
Classification Product Code
GSQ  
Date Received10/31/1995
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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