FDA 510(k) Application Details - K243343

Device Classification Name	More FDA Info for this Device
510(K) Number	K243343
Device Name	BD CTGCTV2
Applicant	BD Integrated Diagnostic Solutions/Becton, Dickinson & Company 7 Loveton Circle Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Teresa Jennifer Sugumar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2024
Decision Date	04/22/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review