FREND Free T4 Test System— 510(k) K152422

Substantially Equivalent

Nanoentek USA, Inc.

FDA 510(k) clearance K152422 for FREND Free T4 Test System, Substantially Equivalent on 2016-02-17. Applicant: Nanoentek USA, Inc..

Clearance details

Applicant: Nanoentek USA, Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 2015-08-26
Decision date: 2016-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, 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.