Roche Ammonia (Various)

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K942048 ↗

FDA Product Code

DKB

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

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 Roche Ammonia Calibrator used for?

  The Roche Ammonia Calibrator is used for the quantitative determination of ammonia in human plasma, in enzymatic in vitro tests on cobas c systems.

• Is the Roche Ammonia Calibrator a single-use or reusable device?

  The device data does not specify whether the Roche Ammonia Calibrator is single-use or reusable, but it is classified as a class 2 device.

• What systems is the Roche Ammonia Calibrator compatible with?

  The Roche Ammonia Calibrator is designed for use on Roche/Hitachi cobas c systems.