Total Protein Assay Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K843028 ↗

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 Total Protein Assay Kit used for?

  The Total Protein Assay Kit is used to determine and measure total protein concentration in clinical chemistry applications, such as following cell lysis, labeling, or purification.

• Is the Total Protein Assay Kit cleared by the FDA?

  Yes, the Total Protein Assay Kit has been cleared under FDA 510K with the number K843028, indicating it is substantially equivalent to a predicate device.

• What type of assay does the Total Protein Assay Kit use?

  The Total Protein Assay Kit uses a Biuret (Colorimetric) Total Protein assay to measure total protein concentration.

• What is the product code for the Total Protein Assay Kit?

  The product code for the Total Protein Assay Kit is CEK.