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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Influenza Virus A, B, C
510(k) Number K061101
Device Name D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
Applicant
Diagnostic Hybrids, Inc.
350 W. State St.
Athens,  OH  45701
Applicant Contact GAIL R GOODRUM
Correspondent
Diagnostic Hybrids, Inc.
350 W. State St.
Athens,  OH  45701
Correspondent Contact GAIL R GOODRUM
Regulation Number866.3330
Classification Product Code
GNW  
Date Received04/20/2006
Decision Date 11/20/2006
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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