Du Pont Total Protein/Albumin Calibrator

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

510(k) Number

K914917 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Aca Iron Calibrator

  Class II

  FDA 510(k) K771802 Active Cleared 25 Oct 1977

• Du Pont Tobramycin Assay Reagents

  Class II

  FDA 510(k) K850058 Active Cleared 18 Jan 1985

• Du Pont Xenolite(Tm) Radiation Protection Apparel

  Class I

  FDA 510(k) K896511 Active Cleared 22 Dec 1989

• Aca Carbon Dioxide Calibrator

  Class II

  FDA 510(k) K771801 Active Cleared 25 Oct 1977

• Du Pont Aca Plus Immunoasssay System Hcg Calibrato

  Class II

  FDA 510(k) K922696 Active Cleared 12 Aug 1992

• Du Pont Analyst Analytical Test Rotor:CHEM-14, Cali

  Class II

  FDA 510(k) K901017 Active Cleared 15 May 1990

See all devices from E.I. Dupont DE Nemours & Co., Inc. →

• What is the Du Pont Total Protein/Albumin Calibrator used for?

  The Du Pont Total Protein/Albumin Calibrator is designed for clinical chemistry laboratories to provide reference standards for quantitative measurement of total protein and albumin levels in serum or plasma. It ensures accuracy and consistency in automated chemistry analyzers, supporting reliable diagnostic assessments of protein metabolism and nutritional status.

• How is the Du Pont Total Protein/Albumin Calibrator supplied?

  This calibrator is supplied in liquid form, specifically formulated for compatibility with automated chemistry systems. It is intended for single-use applications in clinical laboratory settings, ensuring precision and reliability in diagnostic testing.

• Is the Du Pont Total Protein/Albumin Calibrator sterile?

  The provided data does not explicitly state whether the calibrator is sterile. However, as it is intended for in vitro diagnostic use in clinical laboratories, it should be handled under appropriate aseptic conditions to maintain accuracy and safety.

• Can the Du Pont Total Protein/Albumin Calibrator be reused?

  No, the Du Pont Total Protein/Albumin Calibrator is explicitly intended for single-use only. Reusing it could compromise the accuracy of measurements and potentially introduce contamination, which is not recommended for clinical diagnostics.

• What regulatory clearance does the Du Pont Total Protein/Albumin Calibrator hold?

  The calibrator holds FDA 510(k) clearance under the classification of Class II (JIX), with the clearance number K914917. This indicates it has been deemed substantially equivalent to a legally marketed predicate device and meets regulatory standards for clinical chemistry applications.