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FDA 510(k)

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

K-Number: K221802 · 2023-04-03

ApplicantMawi Dna Technologies
Decision Date2023-04-03
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Mawi Dna Technologies. The 510(k) number is K221802.

When was iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) approved by the FDA?

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

What company makes iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is manufactured by Mawi Dna Technologies.

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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Related PubMed Literature

PMID: 41085780 Evaluation of nickel release from Ni-Ti stents in various media for safety assessment purposes. Journal of materials science. Materials in medicine (2025)

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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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