Biuret (Colorimetric), Total Protein

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

510(k) Number

K864743 ↗

FDA Product Code

CEK

Device Class

Class II

Regulation

21 CFR Part 862.1635

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Creatinine

  Class II

  FDA 510(k) K880629 Active Cleared 23 Mar 1988

• Uric Acid

  Class I

  FDA 510(k) K863924 Active Cleared 24 Nov 1986

• Cholesterol

  Class I

  FDA 510(k) K863927 Active Cleared 24 Nov 1986

• Hemoglobin

  Class II

  FDA 510(k) K883683 Active Cleared 6 Oct 1988

• Triglycerides

  Class I

  FDA 510(k) K863923 Active Cleared 24 Nov 1986

• Bilirubin (Direct)

  Class II

  FDA 510(k) K881172 Active Cleared 7 Jun 1988

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• What is the Biuret (Colorimetric), Total Protein reagent used for?

  It is used for the quantitative, colorimetric determination of total protein concentration in solution, employing cupric ions in a biuret assay measured at 37 °C with a 540 nm filter and a side wavelength of 700 nm filter.

• How is the Biuret (Colorimetric), Total Protein reagent supplied and intended for use?

  The device is supplied as a ready-to-use liquid reagent and is intended for use in clinical laboratory settings for protein quantification.

• What regulatory clearance does the Biuret (Colorimetric), Total Protein reagent have?

  It received traditional 510(k) clearance from the FDA under K864743 on January 13, 1987, and is classified as a Class II medical device under regulation number 862.1635 with product code CEK.