Pathfast D-Dimer

FDA 510(k) K072288 · Mitsubishi Kagaku Iatron

Substantially Equivalent

510(k) numberK072288

Submission

Device name
Pathfast D-Dimer
Applicant
Mitsubishi Kagaku Iatron
Seattle, WA, US
Received
August 16, 2007
Decision date
May 6, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GHH – Fibrin Split Products
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7320
Specialty
Hematology

Other 510(k)s with product code GHH

510(k)DeviceApplicantDecision
K112120Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetGHH · Traditional Diazyme Laboratories01/24/2013SE
K070453Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033…GHH · Traditional Olympus Life & Material Science Europa GmbH (Irish06/11/2007SE
K062203Tina-Quant D-Dimer Test SystemGHH · Traditional Roche Diagnostics Corp.03/14/2007SE
K042890Triage D-Dimer Test, Model 98100GHH · Traditional Biosite Incorporated11/29/2004SE
K030740Modification to Tina-Quant D-Dimer Test SystemGHH · Special Roche Diagnostics Corp.04/01/2003SE
K021877Mda D-DimerGHH · Traditional bioMerieux, Inc.08/07/2002SE
K011143Tina-Quant D-Dimer Test SystemGHH · Special Roche Diagnostics Corp.05/29/2001SE
K993276Simplify D-Dimer, Model DCGK1GHH · Traditional Agen Biomedical , Ltd.12/14/1999SE
K972316Opus D-DimerGHH · Traditional Behring Diagnostics, Inc.09/09/1997SE
K945642Agen Dimertest Gold EiaGHH · Traditional Agen Biomedical , Ltd.10/25/1995SE

More from Agen Biomedical , Ltd.

510(k)DeviceDecision
K081360Pathfast Ck-Mb-Ii, Pathfast Myo-IiJHX · Traditional 08/17/2009SE
K083412Pathfast HscrpDCN · Traditional 03/09/2009SE
K072189Pathfast Ntprobnp and D-Dimer TestsNBC · Traditional 02/05/2008SE

Questions and answers

When was Pathfast D-Dimer cleared by the FDA?

Pathfast D-Dimer (K072288) received a 510(k) decision of Substantially Equivalent on May 6, 2009, 629 days after the submission was received.

What is the product code of K072288?

The FDA product code is GHH – Fibrin Split Products, a Class II (moderate risk) device regulated under 21 CFR 864.7320.