iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)— 510(k) K221802

Name: FDA 510(k) clearance K221802
Creator: U.S. Food and Drug Administration
Published: 2023-04-03

Substantially Equivalent

Mawi Dna Technologies

FDA 510(k) clearance K221802 for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL), Substantially Equivalent on 2023-04-03. Applicant: Mawi Dna Technologies. Device class: 2.

Clearance details

Applicant: Mawi Dna Technologies
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2022-06-21
Decision date: 2023-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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