510(k) K925468

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

K925468 is an FDA 510(k) premarket notification submitted by J.J. Skinner, Inc. for the device "JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on April 11, 1994. The device falls under product code GJE (Tray, Blood Collection), a Class II device regulated under 21 CFR 862.1675. J.J. Skinner, Inc. has at least 6 other 510(k) clearances on record.

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