510(k) K120490

QUICK SAMPLER HOLDER by Nipro Medical Corporation — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2012
Date Received
February 17, 2012
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