Cleared Special

R&D CBC-3D + CRP HEMATOLOGY CONTROL

K061511 · R&D Systems, Inc. · Hematology
Jul 2006
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K061511 is an FDA 510(k) clearance for the R&D CBC-3D + CRP HEMATOLOGY CONTROL, 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 review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K061511 FDA.gov
FDA Decision Cleared 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

Device Classification

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