Amuchina/Dialyzer Disinfectant

Q: What is the product code of K852359?

The FDA product code is FKQ – System, Dialysate Delivery, Central Multiple Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.

FDA 510(k) K852359 · Amuchina Intl., Inc.

Substantially Equivalent

510(k) numberK852359

Submission

Device name: Amuchina/Dialyzer Disinfectant
Applicant: Amuchina Intl., Inc.
Washington, DC, US
Received: June 4, 1985
Decision date: May 13, 1986
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: FKQ – System, Dialysate Delivery, Central Multiple Patient
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5820
Specialty: Gastroenterology, Urology
Life-sustaining: Yes

Other 510(k)s with product code FKQ

510(k)	Device	Applicant	Decision
K052764	Diacap Ultra Dialysis Fluid FilterFKQ · Traditional	B. Braun Medizintechnologie GmbH	06/09/2006SE
K893612	Two Tank Dissolution ModuleFKQ · Traditional	National Medical Care, Medical Products Div., Inc.	07/24/1989SE
K874084	Multiple Artificial Kidney Systems (Maks) #IdmFKQ · Traditional	National Medical Care, Medical Products Div., Inc.	04/27/1988SE
K873421	Kawasumi A.V. Fistula SetFKQ · Traditional	Kawasumi Laboratories Co., Ltd.	10/09/1987SE
K870889	Acid Fuchsin SolutionsFKQ · Traditional	D.R.G. Scientific Industries	07/08/1987SE
K861730	Actril for Kidney Machine DisinfectantFKQ · Traditional	Renal Systems, Inc.	06/09/1987SE
K864635	Four Tank Dissolution ModuleFKQ · Traditional	National Medical Care, Medical Products Div., Inc.	01/13/1987SE
K862304	Drake Willock Central Dialysate Delivery SystemFKQ · Traditional	Cd Medical, Inc.	09/09/1986SE
K861472	Maks Central Delivery Systems Models 11-425/11-445FKQ · Traditional	National Medical Care, Medical Products Div., Inc.	07/10/1986SE
K860336	Hemodialysis Concentrates and Related ProductsFKQ · Traditional	Breem Laboratories	03/04/1986SE

More from Breem Laboratories

510(k)	Device	Decision
K992016	Amukin DLIF · Traditional	01/10/2000SE
K952302	AmuchinaLRJ · Traditional	07/26/1995SE
K871583	Modified Labeling for AMUKIN-50%KDJ · Traditional	07/09/1987SE
K862928	AMUKIN-50% for Capd Y-SetFKX · Traditional	03/09/1987SE

Questions and answers

When was Amuchina/Dialyzer Disinfectant cleared by the FDA?

Amuchina/Dialyzer Disinfectant (K852359) received a 510(k) decision of Substantially Equivalent on May 13, 1986, 343 days after the submission was received.

What is the product code of K852359?

The FDA product code is FKQ – System, Dialysate Delivery, Central Multiple Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.