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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K091753
Device Name ELVIS HSV ID AND D3 TYPING TEST SYSTEM
Applicant
Diagnostic Hybrids, Inc.
1055 E. State St., Suite 100
Athens,  OH  45701
Applicant Contact Ronald H Lollar
Correspondent
Diagnostic Hybrids, Inc.
1055 E. State St., Suite 100
Athens,  OH  45701
Correspondent Contact Ronald H Lollar
Regulation Number866.3305
Classification Product Code
GQL  
Date Received06/16/2009
Decision Date 08/28/2009
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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