FDA 510(k) Application Details - K222613

Device Classification Name	Device, Specimen Collection   More FDA Info for this Device
510(K) Number	K222613
Device Name	Device, Specimen Collection
Applicant	ARX Sciences, Inc. 160 Lawrence Bell Drive Suite 120 Amherst, NY 14221 US Other 510(k) Applications for this Company
Contact	Chad Werts Other 510(k) Applications for this Contact
Regulation Number	866.2900   More FDA Info for this Regulation Number
Classification Product Code	LIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2022
Decision Date	03/27/2024
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