DIALYSATE ADDITIVES— 510(k) K842294

Substantially Equivalent

Dialysis Products, Inc.

FDA 510(k) clearance K842294 for DIALYSATE ADDITIVES, Substantially Equivalent on 1984-06-28. Applicant: Dialysis Products, Inc..

Clearance details

Applicant: Dialysis Products, Inc.
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1984-06-11
Decision date: 1984-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.