Cobas Ready Total Protein Reagent

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

510(k) Number

K896230 ↗

FDA Product Code

CEK

Device Class

Class II

Regulation

21 CFR Part 862.1635

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Roche Diagnostic Systems, Inc. →

• What is the COBAS READY Total Protein Reagent used for?

  The COBAS READY Total Protein Reagent is an in vitro test for the quantitative determination of total protein in human serum and plasma on cobas c systems. It is classified as a Biuret (Colorimetric) Total Protein test used in clinical chemistry laboratories.

• How is the COBAS READY Total Protein Reagent supplied?

  The device is supplied as a reagent specifically designed for use with cobas c systems in clinical chemistry laboratory settings. It is manufactured by Roche Diagnostic Systems, Inc. and requires compatibility with the cobas c systems for proper operation.

• What is the regulatory status of the COBAS READY Total Protein Reagent?

  The COBAS READY Total Protein Reagent is regulated under FDA 510K clearance with product code CEK. It has been determined to be substantially equivalent to other predicate devices in its class, as indicated by the decision code SESE.

• What systems is the COBAS READY Total Protein Reagent compatible with?

  The COBAS READY Total Protein Reagent is specifically designed for use with cobas c systems in clinical chemistry laboratories. It is not compatible with other diagnostic systems and requires the cobas platform for proper functionality and accurate results.