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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 Ave. Suite 3
Hayward,  CA  94545
Applicant Contact Bassam EL-Fahmawi
Correspondent
Mawi Dna Technologies
26203 Production Ave. 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
Predetermined Change
Control Plan Authorized		 No
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