FDA 510(k) Application Details - K181092

Device Classification Name	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar   More FDA Info for this Device
510(K) Number	K181092
Device Name	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant	bioMerieux SA 376 Chemin de l'Orme Marcy l'Etoile 69280 FR Other 510(k) Applications for this Company
Contact	Asa Karlsson Other 510(k) Applications for this Contact
Regulation Number	866.1700   More FDA Info for this Regulation Number
Classification Product Code	JSO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2018
Decision Date	07/06/2018
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