Cleared Traditional

George King Coumadin Plasma

K161316 · George King Bio-Medical, Inc. · Hematology
Feb 2017
Decision
288d
Days
Class 2
Risk

About This 510(k) Submission

K161316 is an FDA 510(k) clearance for the George King Coumadin Plasma, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by George King Bio-Medical, Inc. (Overland Park, US). The FDA issued a Cleared decision on February 23, 2017, 288 days after receiving the submission on May 11, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K161316 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2016
Decision Date February 23, 2017
Days to Decision 288 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

Similar Devices — GGN Plasma, Coagulation Control

All 98
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
K170864 · Maine Standards Company, LLC · Jun 2017
VALIDATE Heparin Calibration Verification/Linearity Test Kit
K163498 · Maine Standards Company, LLC · Mar 2017
VALIDATE? D-Dimer Calibration Verification/ Linearity Test Kit
K162705 · Maine Standards Company, LLC · Jan 2017
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
K152961 · Maine Standards Company, LLC · Jun 2016
VisuCon-F Low Fibrinogen Control Plasma
K150144 · Affinity Biologicals, Inc. · Mar 2016
POOL NORM
K142132 · Diagnostics Stago S.A.S. · Dec 2014