Bilirubin Ref., Sigma Stock No. 605-10

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

510(k) Number

K760349 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Sigma Chemical Co. →

• What is the primary purpose of the Bilirubin Ref., Sigma Stock No. 605-10?

  This device is a secondary calibrator specifically designed for use in clinical chemistry applications to assist in the calibration of diagnostic testing equipment.

• What is the regulatory classification of this device?

  The device is classified as a Class II medical device under regulation number 862.1150 and product code JIT, having received FDA 510(k) clearance.

• Who is the manufacturer of this calibrator?

  The Bilirubin Ref., Sigma Stock No. 605-10 is manufactured and supplied by Sigma Chemical Co.