Source document or public record
FDA 510(k) K221802 — iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
FDA 510(k) index record K221802. Device: iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL). Applicant as listed: Mawi Dna Technologies. Decision date: 2023-04-03.
Source
"device_name": "iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)"
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 K221802.
Device name: iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL). Applicant as listed: Mawi Dna Technologies.
Decision date: 2023-04-03. Decision wording: Substantially Equivalent.
Product code: QBD. Regulation: 21 CFR 866.2950. 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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