FDA 510(k) Application Details - K000777

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K000777
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	ITL CORPORATION, PTY LTD. 15825 SHADY GROVE RD. SUITE 90 ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	KENNETH A PALMER 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	03/09/2000
Decision Date	04/11/2000
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