FDA 510(k) Application Details - K162723

Device Classification Name	Tubes, Vacuum Sample, With Anticoagulant   More FDA Info for this Device
510(K) Number	K162723
Device Name	Tubes, Vacuum Sample, With Anticoagulant
Applicant	Caltag Medsystems Ltd. Whiteleaf Business Centre, 11 Little Balmer Buckingham MK18 1TF GB Other 510(k) Applications for this Company
Contact	Daniel Harrison 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	09/29/2016
Decision Date	06/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review