FDA 510(k) Application Details - K183462

Device Classification Name	More FDA Info for this Device
510(K) Number	K183462
Device Name	Applied Biosystems Bacillus anthracis Detection Kit
Applicant	MRIGlobal 425 Volker Boulevard Kansas City, MO 64110 US Other 510(k) Applications for this Company
Contact	Fran White Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2018
Decision Date	10/01/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review