FDA 510(k) Application Details - K220546

Device Classification Name	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation   More FDA Info for this Device
510(K) Number	K220546
Device Name	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant	Copan WASP S.r.l. Via A. Grandi, 32 Brescia 25125 IT Other 510(k) Applications for this Company
Contact	Giovanna Catalano Other 510(k) Applications for this Contact
Regulation Number	866.1645   More FDA Info for this Regulation Number
Classification Product Code	LON Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2022
Decision Date	10/05/2022
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