HPF 100,200,300 CAPILLARY FLOW DIALYZ— 510(k) K822485

Substantially Equivalent

Erika, Inc.

FDA 510(k) clearance K822485 for HPF 100,200,300 CAPILLARY FLOW DIALYZ, Substantially Equivalent on 1982-08-30. Applicant: Erika, Inc..

Clearance details

Applicant: Erika, Inc.
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1982-08-17
Decision date: 1982-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.