Cleared Traditional

PATHFAST D-DIMER

K072288 · Mitsubishi Kagaku Iatron · Hematology
May 2009
Decision
629d
Days
Class 2
Risk

About This 510(k) Submission

K072288 is an FDA 510(k) clearance for the PATHFAST D-DIMER, a Fibrin Split Products (Class II — Special Controls, product code GHH), submitted by Mitsubishi Kagaku Iatron (Seattle, US). The FDA issued a Cleared decision on May 6, 2009, 629 days after receiving the submission on August 16, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K072288 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2007
Decision Date May 06, 2009
Days to Decision 629 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GHH — Fibrin Split Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320

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