FDA 510(k) Application Details - DEN180040

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180040
Device Name	Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
Applicant	Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244 US Other 510(k) Applications for this Company
Contact	Jack Rogers Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2018
Decision Date	11/30/2018
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review