FDA 510(k) Application Details - K971449

Device Classification Name	Tubes, Vacuum Sample, With Anticoagulant   More FDA Info for this Device
510(K) Number	K971449
Device Name	Tubes, Vacuum Sample, With Anticoagulant
Applicant	BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. FRANKLIN LAKES, NJ 07417-1885 US Other 510(k) Applications for this Company
Contact	JOHN A SCHALAGO 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	04/21/1997
Decision Date	06/17/1997
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