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510(k) K191964

Device
BD Kiestra IdentifA
Applicant
Becton, Dickinson And Company
510(k) number
K191964
Product code
QQV  
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-03
Date received
2019-07-23
Regulation
866.3378
Classification name
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Janine Spafford
Address
7 Loveton Cir., Mc 964 Sparks MD US 21152 21152

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QQV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222563BD Kiestra IdentifABecton, Dickinson and Company2023-08-31
K223245ColibríCopan Wasp Srl2023-03-20
K193138Colibri SystemCopan Wasp Srl2021-12-27

Legacy Summary#

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FDA Review#

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