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FDA 510(k)

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)

Número K: K221802 · 2023-04-03

RequerenteMawi Dna Technologies
Data da decisão2023-04-03
Código do produtoQBD
Comité consultivoMI
DecisãoSubstantially Equivalent

Resumo do dispositivo

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is the device name listed in this FDA 510(k) record. The listed applicant is Mawi Dna Technologies. It received FDA 510(k) clearance on 2023-04-03 under 510(k) number K221802. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is a medical device that received FDA 510(k) clearance on 2023-04-03. The listed applicant is Mawi Dna Technologies. The 510(k) number is K221802.

When did iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) receive FDA 510(k) clearance?

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) received FDA 510(k) clearance on 2023-04-03, under 510(k) number K221802.

Who is the listed applicant for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

The FDA 510(k) record lists Mawi Dna Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

The FDA product code for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is QBD.

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