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FDA 510(k)

AMUCHINA/DIALYZER DISINFECTANT

K-Number: K852359 · 1986-05-13

ApplicantAmuchina Intl., Inc.
Decision Date1986-05-13
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMUCHINA/DIALYZER DISINFECTANT is the device name listed in this FDA 510(k) record. The listed applicant is Amuchina Intl., Inc.. It received FDA 510(k) clearance on 1986-05-13 under 510(k) number K852359. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMUCHINA/DIALYZER DISINFECTANT?

AMUCHINA/DIALYZER DISINFECTANT is a medical device that received FDA 510(k) clearance on 1986-05-13. The listed applicant is Amuchina Intl., Inc.. The 510(k) number is K852359.

When did AMUCHINA/DIALYZER DISINFECTANT receive FDA 510(k) clearance?

AMUCHINA/DIALYZER DISINFECTANT received FDA 510(k) clearance on 1986-05-13, under 510(k) number K852359.

Who is the listed applicant for AMUCHINA/DIALYZER DISINFECTANT?

The FDA 510(k) record lists Amuchina Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMUCHINA/DIALYZER DISINFECTANT?

The FDA product code for AMUCHINA/DIALYZER DISINFECTANT is FKQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Amuchina Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992016AMUKIN DK952302AMUCHINAK871583MODIFIED LABELING FOR AMUKIN-50%K862928AMUKIN-50% FOR CAPD Y-SET

Related Devices (Code: FKQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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