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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 K081527
Device Name LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
Applicant
Millipore Corporation
28820 Single Oak Dr.
Temecula,  CA  92590
Applicant Contact ALISHA VU
Correspondent
Millipore Corporation
28820 Single Oak Dr.
Temecula,  CA  92590
Correspondent Contact ALISHA VU
Regulation Number866.3305
Classification Product Code
GQL  
Date Received06/02/2008
Decision Date 04/01/2009
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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