Cleared Special

K061511 - R&D CBC-3D + CRP HEMATOLOGY CONTROL (FDA 510(k) Clearance)

K061511 · R&D Systems, Inc. · Hematology device

Jul 2006

Decision

39d

Days

Class 2

Risk

K061511 is an FDA 510(k) clearance for the R&D CBC-3D + CRP HEMATOLOGY CONTROL. This device is classified as a Mixture, Hematology Quality Control (Class II - Special Controls, product code JPK).

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 10, 2006, 39 days after receiving the submission on June 1, 2006.

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

Submission Details

510(k) Number	K061511 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 01, 2006
Decision Date	July 10, 2006
Days to Decision	39 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF