FDA 510(k) Application Details - K012152

Device Classification Name	Tubes, Vacuum Sample, With Anticoagulant   More FDA Info for this Device
510(K) Number	K012152
Device Name	Tubes, Vacuum Sample, With Anticoagulant
Applicant	DREW SCIENTIFIC LTD. PARK RD.,TELEMETER BLDG. BARROW IN FURNESS LA 14 4QR GB Other 510(k) Applications for this Company
Contact	ANDREW KENNEY Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	GIM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2001
Decision Date	09/18/2001
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