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FDA 510(k)

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

K-Number: K213280 · 2023-05-04

ApplicantBd Kiestra B.V.
Decision Date2023-05-04
Product CodeQQY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App is the device name listed in this FDA 510(k) record. The listed applicant is Bd Kiestra B.V.. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K213280. The device is classified under product code QQY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App?

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Bd Kiestra B.V.. The 510(k) number is K213280.

When did BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App receive FDA 510(k) clearance?

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App received FDA 510(k) clearance on 2023-05-04, under 510(k) number K213280.

Who is the listed applicant for BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App?

The FDA 510(k) record lists Bd Kiestra B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App?

The FDA product code for BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App is QQY.

Related Devices (Code: QQY)

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.

K200839APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis ModuleClever Culture Systems

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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