HemosIL D-Dimer HS 500

Q: What is the product code of K172903?

The FDA product code is DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 864.7320.

FDA 510(k) K172903 · Instrumentation Laboratory CO

Substantially Equivalent

510(k) numberK172903

Submission

Device name: HemosIL D-Dimer HS 500
Applicant: Instrumentation Laboratory CO
Bedford, MA, US
Received: September 22, 2017
Decision date: November 22, 2017
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.7320
Specialty: Hematology

Other 510(k)s with product code DAP

510(k)	Device	Applicant	Decision
K253985	INNOVANCE® D-Dimer 2.0 (SMN 10873803)DAP · Traditional	Siemens Healthcare Diagnostic Products GmbH	08/11/2026SE
K162227	STA® - Liatest® D-DiDAP · Traditional	Diagnostica Stago	12/10/2016SE
K160885	HemosIL D-Dimer HSDAP · Special	Instrumentation Laboratory CO	10/27/2016SE
K151534	HemosIL D-Dimer HSDAP · Special	Instrumentation Laboratory CO	07/06/2015SE
K141144	Sta Liatest D-DiDAP · Traditional	Diagnostica Stago	09/03/2014SE
K112818	Vidas D-Dimer Exclusion II (DEX2)DAP · Traditional	bioMerieux, Inc.	07/31/2012SE
K110303	Stratus CS Acute Care D-DimerDAP · Traditional	Siemens Healthcare Diagnostics	05/16/2011SE
K093626	Innovance D-Dimer, Model OPBP09DAP · Traditional	Siemens Healthcare Diagnostics	11/29/2010SE
K090264	Hemosil D-Dimer HS 500, ControlsDAP · Traditional	Instrumentation Laboratory CO	02/05/2010SE
K091916	Innovance D-Dimer, Model OPBP09DAP · Traditional	Siemens Healthcare Diagnostics	10/29/2009SE

More from Siemens Healthcare Diagnostics

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K223187	HemosIL Liquid Anti-XaQLU · Traditional	06/23/2023SE
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K223090	GEM Premier ChemSTATCGA · Special	01/27/2023SE
K223402	HemosIL von Willebrand Factor AntigenGGP · Special	12/09/2022SE
K213464	HemosIL Liquid Anti-XaKFF · Special	10/04/2022SE
K213426	HemosIL ReadiPlasTinGJS · Traditional	08/16/2022SE

Questions and answers

When was HemosIL D-Dimer HS 500 cleared by the FDA?

HemosIL D-Dimer HS 500 (K172903) received a 510(k) decision of Substantially Equivalent on November 22, 2017, 61 days after the submission was received.

What is the product code of K172903?

The FDA product code is DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 864.7320.