Cleared Traditional

KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501

K032827 · Tyco Healthcare · Hematology

Dec 2003

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K032827 is an FDA 510(k) clearance for the KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501, a Container, Empty, For Collection & Processing Of Blood & Blood Components (Class II — Special Controls, product code KSR), submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on December 8, 2003, 89 days after receiving the submission on September 10, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9100.

Submission Details

510(k) Number	K032827 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2003
Decision Date	December 08, 2003
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF

Device Classification

Product Code	KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.9100