Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control

FDA 510(k) K070453 · Olympus Life & Material Science Europa GmbH (Irish

Substantially Equivalent

510(k) numberK070453

Submission

Device name
Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control
Applicant
Olympus Life & Material Science Europa GmbH (Irish
Irving, TX, US
Received
February 16, 2007
Decision date
June 11, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

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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

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Questions and answers

When was Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control cleared by the FDA?

Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control (K070453) received a 510(k) decision of Substantially Equivalent on June 11, 2007, 115 days after the submission was received.

What is the product code of K070453?

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