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FDA 510(k)

BD Kiestra IdentifA

K-Number: K191964 · 2021-11-03

ApplicantBecton, Dickinson and Company
Decision Date2021-11-03
Product CodeQQV
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD Kiestra IdentifA is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2021-11-03 under 510(k) number K191964. The device is classified under product code QQV. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Kiestra IdentifA?

BD Kiestra IdentifA is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K191964.

When did BD Kiestra IdentifA receive FDA 510(k) clearance?

BD Kiestra IdentifA received FDA 510(k) clearance on 2021-11-03, under 510(k) number K191964.

Who is the listed applicant for BD Kiestra IdentifA?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Kiestra IdentifA?

The FDA product code for BD Kiestra IdentifA is QQV.

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Related Devices (Code: QQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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