FDA 510(k) Application Details - K203336

Device Classification Name	Susceptibility Test Discs, Antimicrobial   More FDA Info for this Device
510(K) Number	K203336
Device Name	Susceptibility Test Discs, Antimicrobial
Applicant	Oxoid Limited (part of Thermo Fisher Scientific) Wade Road Basingstoke RG24 8PW GB Other 510(k) Applications for this Company
Contact	Philip Brame Other 510(k) Applications for this Contact
Regulation Number	866.1620   More FDA Info for this Regulation Number
Classification Product Code	JTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2020
Decision Date	09/15/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review