FDA 510(k) Application Details - K244047

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K244047
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	Venocare, Inc. 3750 NW 87th Avenue, Suite 260 Doral, FL 33178 US Other 510(k) Applications for this Company
Contact	Raul Leyte-Vidal 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	12/31/2024
Decision Date	05/23/2025
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