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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Conjugated Fluorescent, Cytomegalovirus
510(k) Number K081164
Device Name D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
Applicant
Diagnostic Hybrids, Inc.
1055 E. State St., Suite 100
Athens,  OH  45701
Applicant Contact GAIL R GOODRUM
Correspondent
Diagnostic Hybrids, Inc.
1055 E. State St., Suite 100
Athens,  OH  45701
Correspondent Contact GAIL R GOODRUM
Regulation Number866.3175
Classification Product Code
LIN  
Date Received04/24/2008
Decision Date 06/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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