Ca 15-3 Assay for the Advia Integrated Modular System

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K022178 ↗

FDA Product Code

MOI

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

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

• Ammonia Assay for the Advia 1650

  Class I

  FDA 510(k) K023841 Active Cleared 24 Dec 2002

• 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

• 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. →