Sterichek Glutaraldehyde Reagent Strips

Q: What is the product code of K040660?

The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.

FDA 510(k) K040660 · Hach Company

Substantially Equivalent

510(k) numberK040660

Submission

Device name: Sterichek Glutaraldehyde Reagent Strips
Applicant: Hach Company
Elkhart, IN, US
Received: March 12, 2004
Decision date: November 15, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LIF – Dialyzer Reprocessing System
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5820
Specialty: Gastroenterology, Urology

Other 510(k)s with product code LIF

510(k)	Device	Applicant	Decision
K091360	Clearflux Dialyzer Reprocessing SystemLIF · Traditional	Novaflux Technologies	11/03/2010SE
K043126	Assist Header CleanerLIF · Traditional	Alcavis International, Inc.	02/03/2005SE
K033505	Renaclean SH Dialyzer Cleaning SystemLIF · Traditional	Minntech Corp.	04/27/2004SE
K024076	Maky 21.1 Dialyzer Reprocessing SystemLIF · Traditional	Hdc Maquinolas, LLC	09/26/2003SE
K013713	Arm Automatic Reprocessing MachineLIF · Traditional	Alcavis International Incorporated	07/15/2002SE
K992016	Amukin DLIF · Traditional	Amuchina Intl., Inc.	01/10/2000SE
K991851	Renaclear Dialyzer Cleaning SystemLIF · Traditional	Minntech Corp.	08/30/1999SE
K974426	Potency Test Strips, Indicator Test StripsLIF · Traditional	Reprocessing Products Corp	02/10/1999SE
K974798	Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional	Environmental Test Systems, Inc.	03/20/1998SE
K970799	Alexander Manufacturing Rechargeable Battery (M1/T)LIF · Traditional	Alexander Mfg. Co.	05/14/1997SE

More from Alexander Mfg. Co.

510(k)	Device	Decision
K162471	Hach CM130 Chlorine Monitoring SystemPSX · Traditional	03/30/2017SE
K070419	Opaciden Opa Reagent StripsJOJ · Traditional	08/31/2007SE
K042322	Sterichek Blood Leak Reagent StripsFJD · Traditional	12/07/2004SE

Questions and answers

When was Sterichek Glutaraldehyde Reagent Strips cleared by the FDA?

Sterichek Glutaraldehyde Reagent Strips (K040660) received a 510(k) decision of Substantially Equivalent on November 15, 2004, 248 days after the submission was received.

What is the product code of K040660?

The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.