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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
510(k) Number K911345
Device Name HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
Applicant
Diagnostic Hybrids, Inc.
One President St.
Athens,  OH  45701
Applicant Contact JAMES L BROWN
Correspondent
Diagnostic Hybrids, Inc.
One President St.
Athens,  OH  45701
Correspondent Contact JAMES L BROWN
Regulation Number866.3305
Classification Product Code
GQN  
Date Received03/27/1991
Decision Date 06/17/1991
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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