NATURALYTE BICARBONATE DIALYSATE 4400— 510(k) K823115

Substantially Equivalent

Erika, Inc.

FDA 510(k) clearance K823115 for NATURALYTE BICARBONATE DIALYSATE 4400, Substantially Equivalent on 1982-12-03. Applicant: Erika, Inc..

Clearance details

Applicant: Erika, Inc.
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 1982-10-21
Decision date: 1982-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.