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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Blood Culturing
510(k) Number K161810
Device Name BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
Applicant
Becton Dickinson
7 Loveton Circle Mc 694
Sparks,  MD  21152
Applicant Contact Ashanti C. Brown
Correspondent
Becton Dickinson
7 Loveton Circle Mc 694
Sparks,  MD  21152
Correspondent Contact Ashanti C. Brown
Regulation Number866.2560
Classification Product Code
MDB  
Date Received07/01/2016
Decision Date 02/09/2017
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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