FDA 510(k) Application Details - K231282

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K231282
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	LifeOutcomes LLC 88 Inverness Circle East, Unit E-102 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Robert J. McKinnon 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	05/03/2023
Decision Date	01/26/2024
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