FDA 510(k) Application Details - K201009

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K201009
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	CHIRANA T. Injecta Nαm. Dr. Schweitzera 194 Starα Turα 916 01 SK Other 510(k) Applications for this Company
Contact	Zdenka Klbeckova 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	04/17/2020
Decision Date	07/21/2021
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