FDA 510(k) Application Details - K201849

Device Classification Name	More FDA Info for this Device
510(K) Number	K201849
Device Name	eNAT molecular collection and preservation medium
Applicant	Copan Italia S.p.A. Via F. Perotti 10 Brescia 25125 IT Other 510(k) Applications for this Company
Contact	Elena Simeonato Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2020
Decision Date	09/17/2020
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