510(k) K222563

Device

BD Kiestra IdentifA

Applicant

Becton, Dickinson and Company

510(k) number

K222563

Product code

QQV

Decision

Substantially Equivalent (SESE)

Decision date

2023-08-31

Date received

2022-08-24

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