Source document or public record
FDA 510(k) K213280 — BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
FDA 510(k) index record K213280. Device: BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App. Applicant as listed: Bd Kiestra B.V.. Decision date: 2023-05-04.
Source
"device_name": "BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K213280.
Device name: BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App. Applicant as listed: Bd Kiestra B.V..
Decision date: 2023-05-04. Decision wording: Substantially Equivalent.
Product code: QQY. Regulation: 21 CFR 866.2190. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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