Sigma Procedure #550 Determ. Bilirub

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K832236 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Sigma Procedure #550 Determ. Bilirub used for?

  The Sigma Procedure #550 Determ. Bilirub is a clinical chemistry device used for the determination of bilirubin through diazo colorimetry in clinical laboratory settings. It measures bilirubin levels, which are formed from the breakdown of erythrocyte hemoglobin in the reticuloendothelial system.

• How is the Sigma Procedure #550 Determ. Bilirub supplied?

  The device is supplied as a powder with the chemical identifier 635-65-4. It is manufactured by Sigma Chemical Co. and is intended for single-use in clinical chemistry laboratories.

• What is the regulatory status of the Sigma Procedure #550 Determ. Bilirub?

  The device is a Class II device cleared by the FDA under 510(k) number K832236 on August 31, 1983, with a product code of CIG and regulation number 862.1110. It is not specified as MRI safe.

• Is the Sigma Procedure #550 Determ. Bilirub reusable or single-use?

  The device is intended for single-use in clinical chemistry laboratories. It should not be reused for patient testing to ensure accurate results and maintain safety standards.