FDA 510(k) Application Details - K213236

Device Classification Name	More FDA Info for this Device
510(K) Number	K213236
Device Name	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
Applicant	GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Alan Maderazo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2021
Decision Date	04/27/2022
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