FDA 510(k) Application Details - K971111

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K971111
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	TRI-TECH, INC. 4019 EXECUTIVE PARK BLVD.,S.E. SOUTHPORT, NC 28461 US Other 510(k) Applications for this Company
Contact	WENDIE WALKER 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	03/26/1997
Decision Date	06/16/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review