Ultramax III, Dialyzer Reprocessing Device

Q: What is the product code of K860026?

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

FDA 510(k) K860026 · Medicorp, Inc.

Substantially Equivalent

510(k) numberK860026

Submission

Device name: Ultramax III, Dialyzer Reprocessing Device
Applicant: Medicorp, Inc.
Salt Lake City, UT, US
Received: January 3, 1986
Decision date: March 14, 1986
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K040660	Sterichek Glutaraldehyde Reagent StripsLIF · Traditional	Hach Company	11/15/2004SE
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

More from Environmental Test Systems, Inc.

510(k)	Device	Decision
K844850	Medicorp Dehydracon a Dehydrated Dialysate ConcentFKQ · Traditional	04/02/1985SE
K832705	UltramaxLIF · Traditional	06/25/1984SE
K791164	Negatove Pressure ConvertorFLC · Traditional	10/04/1979SE
K791396	Medi-Trak Portable Traction DeviceHST · Traditional	08/16/1979SE

Questions and answers

When was Ultramax III, Dialyzer Reprocessing Device cleared by the FDA?

Ultramax III, Dialyzer Reprocessing Device (K860026) received a 510(k) decision of Substantially Equivalent on March 14, 1986, 70 days after the submission was received.

What is the product code of K860026?

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