Cobas Ready Ldh Reagent

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

510(k) Number

K896241 ↗

FDA Product Code

CFJ

Device Class

Class II

Regulation

21 CFR Part 862.1440

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Abuscreen(R) Radioimmun for Cocaine Metabolite

  Class II

  FDA 510(k) K913722 Active Cleared 10 Sep 1991

• Cobas Core Immunochemistry System

  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

• Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P

  Class II

  FDA 510(k) K952337 Active Cleared 9 Feb 1996

• Roche Abuscreen Ontrak Pos. Ref. Control-Methadone

  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. →

• What is the Cobas Ready Ldh Reagent used for?

  The Cobas Ready Ldh Reagent is used for the quantitative determination of the catalytic activity of lactate dehydrogenase in human serum and plasma.

• Which systems is the Cobas Ready Ldh Reagent compatible with?

  The Cobas Ready Ldh Reagent is supplied for use on various Cobas analyzers, including the Cobas c 303, Cobas c 501, and Cobas Integra systems.

• What is the regulatory status of the Cobas Ready Ldh Reagent?

  The Cobas Ready Ldh Reagent has been authorized with an FDA 510K clearance, with a regulation number of 862.1440.

• What type of settings is the Cobas Ready Ldh Reagent intended for?

  The Cobas Ready Ldh Reagent is intended for use in clinical chemistry settings.