FDA 510(k) Application Details - K211539

Device Classification Name	Susceptibility Test Plate, Antifungal   More FDA Info for this Device
510(K) Number	K211539
Device Name	Susceptibility Test Plate, Antifungal
Applicant	Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 44146 US Other 510(k) Applications for this Company
Contact	Cynthia Knapp Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2021
Decision Date	12/15/2021
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