Enzymatic Bilirubin (Total), Catalogue No. 202-14

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K904660 ↗

FDA Product Code

JFM

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 Enzymatic Bilirubin Total device used for?

  The Enzymatic Bilirubin (Total) device is used for clinical chemistry, specifically for the enzymatic method of bilirubin measurement in a clinical setting.

• Is the Enzymatic Bilirubin Total device supplied sterile?

  The device data does not specify if the device is supplied sterile, but it is intended for use in a clinical setting and regulated under Clinical Chemistry.

• What is the regulatory classification of the Enzymatic Bilirubin Total device?

  The device is classified as a class 2 device with a product code of JFM and regulation number of 862.1110, and has been cleared with FDA 510(k) number K904660.