DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD— 510(k) K843963

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K843963 for DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD, Substantially Equivalent on 1985-01-07. Applicant: Renal Systems, Inc..

Clearance details

Applicant: Renal Systems, Inc.
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1984-10-11
Decision date: 1985-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.