INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls

Q: What is the product code of K162540?

The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.

FDA 510(k) K162540 · Siemens Healthcare Diagnostics Prodcts GmbH

Substantially Equivalent

510(k) numberK162540

Submission

Device name: INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
Applicant: Siemens Healthcare Diagnostics Prodcts GmbH
Marburg, DE
Received: September 12, 2016
Decision date: August 22, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KFF – Assay, Heparin
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.7525
Specialty: Hematology

Other 510(k)s with product code KFF

510(k)	Device	Applicant	Decision
K213464	HemosIL Liquid Anti-XaKFF · Special	Instrumentation Laboratory CO	10/04/2022SE
K111822	Sta(R) - Liquid Anti-Xa, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWHKFF · Traditional	Diagnostica Stago, Inc.	10/26/2011SE
K090209	Hemosil Liquid Heparin, Heparin Calibrators and LMW and Uf Heparin ControlsKFF · Traditional	Instrumentation Laboratory CO	06/02/2009SE
K050367	Biophen Heparin 3, Biophen Heparin 6KFF · Traditional	Hyphen Biomed	05/24/2006SE
K013305	Enoxaparin Test CardKFF · Traditional	Cardiovascular Diagnostics, Inc.	08/23/2002SE
K013637	Actichrome Heparin (Anti-Fiia)KFF · Traditional	American Diagnostica, Inc.	04/16/2002SE
K013318	Actichrome Heparin (Anti-Fxa), Model 832KFF · Traditional	American Diagnostica, Inc.	03/08/2002SE
K010455	Rotachrom Heparin and Sta -Rotachrom HeparinKFF · Traditional	Diagnostica-Stago	06/07/2001SE
K010193	Hemochron Kaolin-Activated Heparin and Protamine Dosing AssaysKFF · Traditional	International Technidyne Corp.	06/06/2001SE
K983178	Coamatic HeparinKFF · Traditional	Instrumentation Laboratory CO	11/03/1998SE

Questions and answers

When was INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls cleared by the FDA?

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls (K162540) received a 510(k) decision of Substantially Equivalent on August 22, 2017, 344 days after the submission was received.

What is the product code of K162540?

The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.