FDA 510(k) Application Details - DEN180030

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180030
Device Name	QMS Plazomicin Immunoassay
Applicant	Microgenics Corporation 46500 Kato Road Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Minoti Patel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2018
Decision Date	11/19/2018
Decision	DENG -
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review