C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT— 510(k) K811566

Substantially Equivalent

Immuno Nuclear Corp.

FDA 510(k) clearance K811566 for C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1981-06-25. Applicant: Immuno Nuclear Corp..

Clearance details

Applicant: Immuno Nuclear Corp.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1981-06-04
Decision date: 1981-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.