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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 K222563
Device Name BD Kiestra IdentifA
Applicant
Becton, Dickinson and Company
7 Loveton Circle
Mail Code 694
Sparks,  MD  21152
Applicant Contact Laura Stewart
Correspondent
Becton, Dickinson and Company
7 Loveton Circle
Mail Code 694
Sparks,  MD  21152
Correspondent Contact Laura Stewart
Regulation Number866.3378
Classification Product Code
QQV  
Subsequent Product Code
QBN  
Date Received08/24/2022
Decision Date 08/31/2023
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
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