510(k) K093910

IMPROVACUTER GEL & CLOT ACTIVATOR TUBE by Guangzhou Improve Medical Instruments Co., Ltd. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2010
Date Received
December 22, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type