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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
510(k) Number K101514
Device Name BD DIRECTIGEN EZ RSV
Applicant
Becton, Dickinson & CO
11085 N. Torrey Pines Rd.
Suite 210
La Jolla,  CA  92037
Applicant Contact Gregory P Payne
Correspondent
Becton, Dickinson & CO
11085 N. Torrey Pines Rd.
Suite 210
La Jolla,  CA  92037
Correspondent Contact Gregory P Payne
Regulation Number866.3480
Classification Product Code
GQG  
Date Received06/02/2010
Decision Date 07/09/2010
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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