SPAC T3 RIA TEST KIT— 510(k) K801125

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K801125 for SPAC T3 RIA TEST KIT, Substantially Equivalent on 1980-06-09. Applicant: Mallinckrodt Critical Care.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1980-05-12
Decision date: 1980-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.