HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES— 510(k) K860297

Substantially Equivalent

Renal Hygienics

FDA 510(k) clearance K860297 for HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES, Substantially Equivalent on 1986-03-04. Applicant: Renal Hygienics.

Clearance details

Applicant: Renal Hygienics
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1986-01-28
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarzana, CA, US

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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.