Easy-Test Total Protein (TP) Item Number: 19011

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K874476 ↗

FDA Product Code

CEK

Device Class

Class II

Regulation

21 CFR Part 862.1635

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Easy-Test Total Protein (TP) device used for?

  The Easy-Test Total Protein (TP) is a clinical chemistry device used for the colorimetric determination of total protein levels in biological samples. It operates based on the Biuret method, which is a standard laboratory technique for protein quantification.

• How is the Easy-Test Total Protein (TP) supplied and what are its handling requirements?

  The Easy-Test Total Protein (TP) is supplied as a single-use device and is intended for laboratory use only. It is stored at room temperature and does not require special handling conditions, making it convenient for routine laboratory testing.

• What is the regulatory classification of the Easy-Test Total Protein (TP) device?

  The Easy-Test Total Protein (TP) has received FDA 510(k) clearance with product code CEK and is classified as a Class II medical device, indicating it meets specific regulatory requirements for safety and effectiveness in clinical laboratory settings.

• Can the Easy-Test Total Protein (TP) device be reused?

  No, the Easy-Test Total Protein (TP) is designed as a single-use device only. After use, it should be properly disposed of according to laboratory protocols and regulatory guidelines for medical waste disposal.