FDA 510(k) Application Details - DEN170041

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170041
Device Name	GeneSTAT.MDx Coccidioides Assay
Applicant	DxNA, LLC 180 N 300 E St George, UT 84770 US Other 510(k) Applications for this Company
Contact	Ernie Sumsion Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2017
Decision Date	11/29/2017
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