BD Kiestra IdentifA

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Kiestra Identifa.

Pre-market Notification Details

Device IDK191964
510k NumberK191964
Device Name:BD Kiestra IdentifA
ClassificationAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Applicant Becton, Dickinson And Company 7 Loveton Circle, MC 964 Sparks,  MD  21152
ContactJanine Spafford
CorrespondentLaura Stewart
Becton, Dickinson And Company 7 Loveton Circle, MC 964 Sparks,  MD  21152
Product CodeQQV  
CFR Regulation Number866.3378 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-23
Decision Date2021-11-03

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