Cleared Traditional

BC-5D Hematology Control

K160606 · R&D Systems, Inc. · Hematology
Sep 2016
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K160606 is an FDA 510(k) clearance for the BC-5D 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 September 1, 2016, 183 days after receiving the submission on March 2, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K160606 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2016
Decision Date September 01, 2016
Days to Decision 183 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