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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, Human Metapneumovirus
510(k) Number K093815
Device Name LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
Applicant
Millipore Corporation
28820 Single Oak Dr.
Temecula,  CA  92590
Applicant Contact CATHERINE KARAMAN
Correspondent
Millipore Corporation
28820 Single Oak Dr.
Temecula,  CA  92590
Correspondent Contact CATHERINE KARAMAN
Regulation Number866.3980
Classification Product Code
OMG  
Date Received12/14/2009
Decision Date 03/12/2010
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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