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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 K932622
Device Name CHOLERA SMART(TM)
Applicant
New Horizons Diagnostics Co.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Applicant Contact JOHN TARTAL
Correspondent
New Horizons Diagnostics Co.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Correspondent Contact JOHN TARTAL
Regulation Number866.3930
Classification Product Code
GSQ  
Date Received06/01/1993
Decision Date 06/27/1995
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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