CIBA CORNING ACS FT4 IMMUNOASSAY— 510(k) K910684

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K910684 for CIBA CORNING ACS FT4 IMMUNOASSAY, Substantially Equivalent on 1991-05-01. Applicant: Ciba Corning Diagnostics Corp..

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1991-02-19
Decision date: 1991-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

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Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.