510(k) K854391— HEMODIALYSIS CONCENTRATE

Substantially Equivalent

Dana Laboratories

Clearance details

Applicant: Dana Laboratories
Product code: Code FKQ
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

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.