510(k) K925468

JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT by J.J. Skinner, Inc. — Product Code GJE

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
April 11, 1994
Date Received
October 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type