FDA 510(k) Application Details - K163073

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K163073
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	Sol-Millennium Medical, Inc. 1735 North Brown Road, Suite 120 Lawrenceville, GA 30043 US Other 510(k) Applications for this Company
Contact	Jim Barley 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	11/02/2016
Decision Date	05/19/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review