Cleared Traditional

K060464 - COULTER 5C CELL CONTROL (FDA 510(k) Clearance)

K060464 · Beckman Coulter, Inc. · Hematology device

Mar 2006

Decision

34d

Days

Class 2

Risk

K060464 is an FDA 510(k) clearance for the COULTER 5C CELL CONTROL. 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 March 28, 2006, 34 days after receiving the submission on February 22, 2006.

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

Submission Details

510(k) Number	K060464 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 22, 2006
Decision Date	March 28, 2006
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF