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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 a medical device manufactured by Bd Kiestra B.V.. It received FDA 510(k) clearance on 2023-05-04 under approval 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. It is manufactured by Bd Kiestra B.V.. The 510(k) number is K213280.

When was BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App approved by the FDA?

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

What company makes 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 manufactured by Bd Kiestra B.V..

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.

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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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