Cleared Traditional

DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC

K120977 · International Technidyne Corp. · Hematology
Jul 2013
Decision
457d
Days
Class 2
Risk

About This 510(k) Submission

K120977 is an FDA 510(k) clearance for the DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on July 3, 2013, 457 days after receiving the submission on April 2, 2012. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K120977 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2012
Decision Date July 03, 2013
Days to Decision 457 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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