Cleared Traditional

CSF AUTOMATED CONTROL, MODELS CSF001, CSF003

K072846 · R&D Systems, Inc. · Hematology
Nov 2007
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K072846 is an FDA 510(k) clearance for the CSF AUTOMATED CONTROL, MODELS CSF001, CSF003, 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 review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K072846 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625