Ammonia Assay for the Advia 1650

• • Terminated Z-1646-2018 FDA Class II ·initiated 29 Jun 2017

  Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

510(k) Number

K023841 ↗

FDA Product Code

JIF

Device Class

Class I

Regulation

21 CFR Part 862.1065

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Salicylate Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K020794 Active Cleared 11 Jul 2002

• Bayer Special Chemistry Controls

  Class I

  FDA 510(k) K033379 Active Cleared 19 Dec 2003

• Uric Acid Assay for the Advia Integrated Modular System

  Class I

  FDA 510(k) K022096 Active Cleared 18 Mar 2003

• Bayer Special Chemistry Calibrators

  Class II

  FDA 510(k) K033380 Active Cleared 16 Dec 2003

• Ca 15-3 Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K022178 Active Cleared 12 Nov 2002

• Advia 120 Hematology System, Cerebrospinal Fluid Method

  Class II

  FDA 510(k) K022331 Active Cleared 11 Sep 2002

See all devices from Bayer Diagnostics Corp. →