KNAI SODIUM POTASSIUM ANALYZER— 510(k) K830805

Substantially Equivalent

Radiometer America, Inc.

FDA 510(k) clearance K830805 for KNAI SODIUM POTASSIUM ANALYZER, Substantially Equivalent on 1983-04-08. Applicant: Radiometer America, Inc..

Clearance details

Applicant: Radiometer America, Inc.
Product code: Code JSG
Advisory panel: Microbiology
Date received: 1983-03-14
Decision date: 1983-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JSG

product code JSG

Malfunction: 817
Total: 817

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.