COMPUDIAL/KP-1

FDA 510(k) K813107 · Computer Dialysis Systems, Inc.

Substantially Equivalent

510(k) numberK813107

Submission

Device name
COMPUDIAL/KP-1
Applicant
Computer Dialysis Systems, Inc.
Mchenry, IL, US
Received
November 3, 1981
Decision date
March 23, 1982
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)DeviceApplicantDecision
K091360Clearflux Dialyzer Reprocessing SystemLIF · Traditional Novaflux Technologies11/03/2010SE
K043126Assist Header CleanerLIF · Traditional Alcavis International, Inc.02/03/2005SE
K040660Sterichek Glutaraldehyde Reagent StripsLIF · Traditional Hach Company11/15/2004SE
K033505Renaclean SH Dialyzer Cleaning SystemLIF · Traditional Minntech Corp.04/27/2004SE
K024076Maky 21.1 Dialyzer Reprocessing SystemLIF · Traditional Hdc Maquinolas, LLC09/26/2003SE
K013713Arm Automatic Reprocessing MachineLIF · Traditional Alcavis International Incorporated07/15/2002SE
K992016Amukin DLIF · Traditional Amuchina Intl., Inc.01/10/2000SE
K991851Renaclear Dialyzer Cleaning SystemLIF · Traditional Minntech Corp.08/30/1999SE
K974426Potency Test Strips, Indicator Test StripsLIF · Traditional Reprocessing Products Corp02/10/1999SE
K974798Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional Environmental Test Systems, Inc.03/20/1998SE

More from Environmental Test Systems, Inc.

510(k)DeviceDecision
K850127Forma-Tag Usp Sodium Chloride Package 80GM & 120 GLIF · Traditional 03/20/1985SE
K831132COMPUDIAL/KP-1LIF · Traditional 08/08/1983SE
K820575J.E.T. Dialysis SystemFKJ · Traditional 05/20/1982SE

Questions and answers

When was COMPUDIAL/KP-1 cleared by the FDA?

COMPUDIAL/KP-1 (K813107) received a 510(k) decision of Substantially Equivalent on March 23, 1982, 140 days after the submission was received.

What is the product code of K813107?

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