FDA 510(k) Application Details - K230493

Device Classification Name	Tubes, Vacuum Sample, With Anticoagulant   More FDA Info for this Device
510(K) Number	K230493
Device Name	Tubes, Vacuum Sample, With Anticoagulant
Applicant	Becton Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417 US Other 510(k) Applications for this Company
Contact	Katherine Kenner Lemus Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	GIM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2023
Decision Date	11/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review