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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 K091171
Device Name D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
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 Number866.3980
Classification Product Code
OMG  
Subsequent Product Codes
GNS   GNY   GQS   LKT  
Date Received04/22/2009
Decision Date 09/11/2009
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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