FDA 510(k) Application Details - K203748

Device Classification Name	More FDA Info for this Device
510(K) Number	K203748
Device Name	SeptiCyte RAPID
Applicant	Immunexpress, Inc 425 Pontius Avenue North, Suite 470 Seattle, WA 98109 US Other 510(k) Applications for this Company
Contact	LaKesha Hunt-Dickens Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2020
Decision Date	11/29/2021
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