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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
510(k) Number K191964
Device Name BD Kiestra IdentifA
Applicant
Becton, Dickinson and Company
7 Loveton Cir., Mc 964
Sparks,  MD  21152
Applicant Contact Janine Spafford
Correspondent
Becton, Dickinson and Company
7 Loveton Cir., Mc 964
Sparks,  MD  21152
Correspondent Contact Laura Stewart
Classification Product Code
QQV  
Subsequent Product Code
QBN  
Date Received07/23/2019
Decision Date 11/03/2021
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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