AMUCHINA/DIALYZER DISINFECTANT— 510(k) K852359

Name: FDA 510(k) clearance K852359
Creator: U.S. Food and Drug Administration
Published: 1986-05-13

Substantially Equivalent

Amuchina Intl., Inc.

FDA 510(k) clearance K852359 for AMUCHINA/DIALYZER DISINFECTANT, Substantially Equivalent on 1986-05-13. Applicant: Amuchina Intl., Inc.. Device class: 2.

Clearance details

Applicant: Amuchina Intl., Inc.
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-06-04
Decision date: 1986-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K992016 — AMUKIN D2000-01-10
K952302 — AMUCHINA1995-07-26
K871583 — MODIFIED LABELING FOR AMUKIN-50%1987-07-09
K862928 — AMUKIN-50% FOR CAPD Y-SET1987-03-09

Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.