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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Neutralization, Herpesvirus Hominis
510(k) Number K875367
Device Name COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV
Applicant
Enzo Biochem, Inc.
325 Hudson St.
New York,  NY  10013
Applicant Contact PAULA OLSIEWSKI
Correspondent
Enzo Biochem, Inc.
325 Hudson St.
New York,  NY  10013
Correspondent Contact PAULA OLSIEWSKI
Regulation Number866.3305
Classification Product Code
GQM  
Date Received12/31/1987
Decision Date 03/28/1988
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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