FDA 510(k) Application Details - K192050

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K192050
Device Name	Manual Antimicrobial Susceptibility Test Systems
Applicant	bioMerieux SA 376 Chemin de lÆOrme Marcy-lÆEtoile 69280 FR Other 510(k) Applications for this Company
Contact	Marine Taravant Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	JWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2019
Decision Date	09/27/2019
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