FDA 510(k) Application Details - K191918

Device Classification Name	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems   More FDA Info for this Device
510(K) Number	K191918
Device Name	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant	Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 440146 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	LRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2019
Decision Date	11/06/2019
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