AMUCHINA— 510(k) K952302

Name: FDA 510(k) clearance K952302
Creator: U.S. Food and Drug Administration
Published: 1995-07-26

Substantially Equivalent

Amuchina Intl., Inc.

FDA 510(k) clearance K952302 for AMUCHINA, Substantially Equivalent on 1995-07-26. Applicant: Amuchina Intl., Inc.. Device class: 1.

Clearance details

Applicant: Amuchina Intl., Inc.
Product code: Code LRJ
Device class: Class 1
Regulation: 21 CFR 880.6890
Advisory panel: General Hospital
Date received: 1995-05-16
Decision date: 1995-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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K871583 — MODIFIED LABELING FOR AMUKIN-50%1987-07-09
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K852359 — AMUCHINA/DIALYZER DISINFECTANT1986-05-13

Adverse events under product code LRJ

product code LRJ

Injury: 958
Total: 958

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.