Cleared Traditional

HEMOSIL D-DIMER HS 500 CONTROL

K133582 · Instrumentation Laboratory · Hematology
Aug 2014
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K133582 is an FDA 510(k) clearance for the HEMOSIL D-DIMER HS 500 CONTROL, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Instrumentation Laboratory (Bedford, US). The FDA issued a Cleared decision on August 15, 2014, 267 days after receiving the submission on November 21, 2013. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K133582 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2013
Decision Date August 15, 2014
Days to Decision 267 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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

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