FDA 510(k) Application Details - K221802

Device Classification Name	More FDA Info for this 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 US Other 510(k) Applications for this Company
Contact	Bassam EL-Fahmawi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2022
Decision Date	04/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review