DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL— 510(k) K981043

Substantially Equivalent

Solution Technologies

FDA 510(k) clearance K981043 for DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL, Substantially Equivalent on 1998-05-26. Applicant: Solution Technologies.

Clearance details

Applicant: Solution Technologies
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1998-03-20
Decision date: 1998-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Ogden, UT, US

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Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.