Cleared Special

R&D LH-NRBC HEMATOLOGY CONTROL

K061320 · R&D Systems, Inc. · Hematology
Jun 2006
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K061320 is an FDA 510(k) clearance for the R&D LH-NRBC 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 June 2, 2006, 22 days after receiving the submission on May 11, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K061320 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2006
Decision Date June 02, 2006
Days to Decision 22 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