FDA 510(k) Application Details - K232308

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K232308
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	The Monarch Company 4000 Eagle Point Corporate Drive Birmingham, AL 35242 US Other 510(k) Applications for this Company
Contact	Jonathan Trawick Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	JKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2023
Decision Date	12/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review