CODE IM 2050 AMERLEX FREE T4 RIA KIT— 510(k) K810231

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K810231 for CODE IM 2050 AMERLEX FREE T4 RIA KIT, Substantially Equivalent on 1981-02-10. Applicant: Amersham Corp..

Clearance details

Applicant: Amersham Corp.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1981-01-27
Decision date: 1981-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.