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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 K870733
Device Name COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
Applicant
Enzo Biochem, Inc.
325 Hudson St.
New York,  NY  10013
Applicant Contact OLSIEWSKI, PHD
Correspondent
Enzo Biochem, Inc.
325 Hudson St.
New York,  NY  10013
Correspondent Contact OLSIEWSKI, PHD
Regulation Number866.3305
Classification Product Code
GQN  
Date Received02/25/1987
Decision Date 05/26/1987
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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