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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microbial Nucleic Acid Storage And Stabilization Device
510(k) Number K221802
Device Name iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
Applicant
Mawi DNA Technologies
26203 Production Avenue, Suite 3
Hayward,  CA  94545
Applicant Contact Bassam EL-Fahmawi
Correspondent
Mawi DNA Technologies
26203 Production Avenue, Suite 3
Hayward,  CA  94545
Correspondent Contact Bassam EL-Fahmawi
Classification Product Code
QBD  
Date Received06/21/2022
Decision Date 04/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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