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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 K090073
Device Name D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
Applicant
DIAGNOSTIC HYBRIDS, INC.
1055 EAST STATE STREET
SUITE 100
ATHENS,  OH  45701
Applicant Contact GAIL R GOODRUM
Correspondent
DIAGNOSTIC HYBRIDS, INC.
1055 EAST STATE STREET
SUITE 100
ATHENS,  OH  45701
Correspondent Contact GAIL R GOODRUM
Regulation Number866.3980
Classification Product Code
OMG  
Date Received01/12/2009
Decision Date 03/06/2009
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
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