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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 K873529
Device Name HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
Applicant
Diagnostic Hybrids, Inc.
One President St.
Athens,  OH  45701
Applicant Contact SCHOLL, PHD
Correspondent
Diagnostic Hybrids, Inc.
One President St.
Athens,  OH  45701
Correspondent Contact SCHOLL, PHD
Regulation Number866.3305
Classification Product Code
GQN  
Date Received09/01/1987
Decision Date 08/25/1988
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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