FDA 510(k) Application Details - K983490

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K983490
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	TERUMO CORP. 125 BLUE BALL RD. ELKTON, MD 21921 US Other 510(k) Applications for this Company
Contact	KRISTINE WAGNER 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	10/05/1998
Decision Date	11/30/1998
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