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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), Cytomegalovirus
510(k) Number K872576
Device Name COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION
Applicant
Enzo Biochem, Inc.
325 Hudson St.
New York,  NY  10013
Applicant Contact PAULA J OLSIEWSKI
Correspondent
Enzo Biochem, Inc.
325 Hudson St.
New York,  NY  10013
Correspondent Contact PAULA J OLSIEWSKI
Regulation Number866.3175
Classification Product Code
GQH  
Date Received06/30/1987
Decision Date 12/04/1987
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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