HEMODIALYSIS CONCENTRATE— 510(k) K854391

Name: FDA 510(k) clearance K854391
Creator: U.S. Food and Drug Administration
Published: 1986-01-08

Substantially Equivalent

Dana Laboratories

FDA 510(k) clearance K854391 for HEMODIALYSIS CONCENTRATE, Substantially Equivalent on 1986-01-08. Applicant: Dana Laboratories. Device class: 2.

Clearance details

Applicant: Dana Laboratories
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-10-31
Decision date: 1986-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

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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.