Cleared Traditional

VALIDATE Heparin Calibration Verification/Linearity Test Kit

K163498 · Maine Standards Company, LLC · Hematology
Mar 2017
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K163498 is an FDA 510(k) clearance for the VALIDATE Heparin 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 March 16, 2017, 93 days after receiving the submission on December 13, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K163498 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2016
Decision Date March 16, 2017
Days to Decision 93 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

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