Cleared Traditional

R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL

K101578 · R&D Systems, Inc. · Hematology
Apr 2011
Decision
325d
Days
Class 2
Risk

About This 510(k) Submission

K101578 is an FDA 510(k) clearance for the R&D SYSTEMS BODY FLUID-I 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 April 28, 2011, 325 days after receiving the submission on June 7, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K101578 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2010
Decision Date April 28, 2011
Days to Decision 325 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