FDA 510(k) Application Details - K191288

Device Classification Name	More FDA Info for this Device
510(K) Number	K191288
Device Name	Acuitas AMR Gene Panel
Applicant	OpGen, Inc. 9717 Key West Avenue Suite 100 Rockville, MD 20850 US Other 510(k) Applications for this Company
Contact	Autumn Collasius Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2019
Decision Date	09/30/2021
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