TRIOBEAD-125 DIAGNOSTIC KIT— 510(k) K771236

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K771236 for TRIOBEAD-125 DIAGNOSTIC KIT, Substantially Equivalent on 1977-08-03. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1977-07-11
Decision date: 1977-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, 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.