FDA 510(k) Application Details - K212204

Device Classification Name	More FDA Info for this Device
510(K) Number	K212204
Device Name	Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Cont
Applicant	CD Diagnostics Inc 650 Naamans Road Suite 100 Claymont, DE 19703 US Other 510(k) Applications for this Company
Contact	Pragnya Bakka 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	07/15/2021
Decision Date	08/11/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review