Cleared Traditional

VALIDATE? D-Dimer Calibration Verification/ Linearity Test Kit

K162705 · Maine Standards Company, LLC · Hematology
Jan 2017
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K162705 is an FDA 510(k) clearance for the VALIDATE? D-Dimer Calibration Verification/ Linearity Test Kit, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Maine Standards Company, LLC (Cumberland Foreside, US). The FDA issued a Cleared decision on January 5, 2017, 99 days after receiving the submission on September 28, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K162705 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2016
Decision Date January 05, 2017
Days to Decision 99 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
George King Coumadin Plasma
K161316 · George King Bio-Medical, Inc. · Feb 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