FDA 510(k) Application Details - K191167

Device Classification Name	Antigen, Invasive Fungal Pathogens   More FDA Info for this Device
510(K) Number	K191167
Device Name	Antigen, Invasive Fungal Pathogens
Applicant	Associates of Cape Cod, Inc 124 Bernard East Saint Jean Drive East Falmouth, MA 02536 US Other 510(k) Applications for this Company
Contact	Alison Skinner Other 510(k) Applications for this Contact
Regulation Number	866.3050   More FDA Info for this Regulation Number
Classification Product Code	NQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2019
Decision Date	07/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review