FDA 510(k) Application Details - K213718

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K213718
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	Sol-Millennium Medical, Inc. 315 Shawnee North Drive Suwanee, GA 30024 US Other 510(k) Applications for this Company
Contact	PJ Pasia 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	11/24/2021
Decision Date	08/30/2022
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