FDA 510(k) Application Details - DEN180032

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180032
Device Name	Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Cont
Applicant	CD Diagnostics Inc. 650 Naamans Road, Suite 100 Claymount, DE 19703 US Other 510(k) Applications for this Company
Contact	Sujith Kallur Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2018
Decision Date	05/23/2019
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