Cleared Traditional

K013842 - IMMUNO-TROL LOW CELLS (FDA 510(k) Clearance)

K013842 · Beckman Coulter, Inc. · Hematology device

Dec 2001

Decision

23d

Days

Class 2

Risk

K013842 is an FDA 510(k) clearance for the IMMUNO-TROL LOW CELLS. This device is classified as a Mixture, Hematology Quality Control (Class II - Special Controls, product code JPK).

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on December 13, 2001, 23 days after receiving the submission on November 20, 2001.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K013842 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 20, 2001
Decision Date	December 13, 2001
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF