FDA 510(k) Application Details - K080552

Device Classification Name	Tubes, Vacuum Sample, With Anticoagulant   More FDA Info for this Device
510(K) Number	K080552
Device Name	Tubes, Vacuum Sample, With Anticoagulant
Applicant	Streck 7002 SOUTH 109TH ST. OMAHA, NE 68128 US Other 510(k) Applications for this Company
Contact	CARL THOMPSON 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	02/28/2008
Decision Date	07/31/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review