Amukin D

FDA 510(k) K992016 · Amuchina Intl., Inc.

Substantially Equivalent

510(k) numberK992016

Submission

Device name
Amukin D
Applicant
Amuchina Intl., Inc.
Gaithersburg, MD, US
Received
June 15, 1999
Decision date
January 10, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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)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
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
K970799Alexander Manufacturing Rechargeable Battery (M1/T)LIF · Traditional Alexander Mfg. Co.05/14/1997SE

More from Alexander Mfg. Co.

510(k)DeviceDecision
K952302AmuchinaLRJ · Traditional 07/26/1995SE
K871583Modified Labeling for AMUKIN-50%KDJ · Traditional 07/09/1987SE
K862928AMUKIN-50% for Capd Y-SetFKX · Traditional 03/09/1987SE
K852359Amuchina/Dialyzer DisinfectantFKQ · Traditional 05/13/1986SE

Questions and answers

When was Amukin D cleared by the FDA?

Amukin D (K992016) received a 510(k) decision of Substantially Equivalent on January 10, 2000, 209 days after the submission was received.

What is the product code of K992016?

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