Cleared Traditional

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

K170864 · Maine Standards Company, LLC · Hematology
Jun 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K170864 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 June 21, 2017, 90 days after receiving the submission on March 23, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K170864 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2017
Decision Date June 21, 2017
Days to Decision 90 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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