AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA— 510(k) K860251

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K860251 for AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA, Substantially Equivalent on 1986-02-11. Applicant: Amersham Corp..

Clearance details

Applicant: Amersham Corp.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1986-01-24
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, 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.