HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER— 510(k) K012328

Substantially Equivalent

Di-Chem, Inc.

FDA 510(k) clearance K012328 for HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER, Substantially Equivalent on 2002-01-18. Applicant: Di-Chem, Inc..

Clearance details

Applicant: Di-Chem, Inc.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-23
Decision date: 2002-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Champlin, MN, 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.