FDA 510(k) Application Details - K181743

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K181743
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	NSP Tech Pte Ltd 45A Macpherson Road Singapore 348470 SG Other 510(k) Applications for this Company
Contact	HC Tan 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	07/02/2018
Decision Date	07/30/2019
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