K833252

Substantially Equivalent

ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF

Applicant: Erika, Inc.
Product code: KOC
Advisory panel: Gastroenterology, Urology
Date received: 1983-09-20
Decision date: 1983-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.