CORNING'S MAGIC T3(125I) RADIOIMMUNO-— 510(k) K832353

Name: FDA 510(k) clearance K832353
Creator: U.S. Food and Drug Administration
Published: 1983-08-31

Substantially Equivalent

Corning Medical & Scientific

FDA 510(k) clearance K832353 for CORNING'S MAGIC T3(125I) RADIOIMMUNO-, Substantially Equivalent on 1983-08-31. Applicant: Corning Medical & Scientific. Device class: 2.

Clearance details

Applicant: Corning Medical & Scientific
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1983-07-18
Decision date: 1983-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.