Cleared Traditional

K072846 - CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 (FDA 510(k) Clearance)

K072846 · R&D Systems, Inc. · Hematology device

Nov 2007

Decision

53d

Days

Class 2

Risk

K072846 is an FDA 510(k) clearance for the CSF AUTOMATED CONTROL, MODELS CSF001, CSF003. 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 November 26, 2007, 53 days after receiving the submission on October 4, 2007.

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

Submission Details

510(k) Number	K072846 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 04, 2007
Decision Date	November 26, 2007
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF