Cobas Ready Total Bilirubin Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K896232 ↗

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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  Class II

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  Class I

  FDA 510(k) K962231 Active Cleared 30 Aug 1996

• Roche Reagent for Apolipoprotein B

  Class I

  FDA 510(k) K910552 Active Cleared 7 May 1991

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  FDA 510(k) K952337 Active Cleared 9 Feb 1996

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  Class I

  FDA 510(k) K930844 Active Cleared 27 Jan 1994

• Ontrak Testcup Amphetamines

  Class II

  FDA 510(k) K962411 Active Cleared 7 Oct 1996

See all devices from Roche Diagnostic Systems, Inc. →