FDA 510(k) Application Details - K240279

Device Classification Name	More FDA Info for this Device
510(K) Number	K240279
Device Name	VIDAS TBI (GFAP, UCH-L1)
Applicant	Biomerieux Inc. 595 Anglum Rd. Hazelwood, MO 63042 US Other 510(k) Applications for this Company
Contact	Chris Goodpaster Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2024
Decision Date	05/01/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review