Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K022288 ↗

FDA Product Code

LTJ

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Estradiol Assay for the Technicon Immuno 1 System in-Vitro Diagnostic System

  Class I

  FDA 510(k) K951360 Active Cleared 2 May 1995

• 8 Additional Assays for the Bayer Advia 1650 Chemistry System Open recall

  Class I

  FDA 510(k) K992662 Active Cleared 15 Feb 2000

• Clinitek Hcg Test Strips

  Class II

  FDA 510(k) K971209 Active Cleared 4 Apr 1997

• Bayer Diagnostics ACS:180 VB12, Bayer Diagnostics Advia Centaue VB12

  Class II

  FDA 510(k) K993571 Active Cleared 16 Dec 1999

• Glucometer Elite Xl Blood Glucose Meter

  Class II

  FDA 510(k) K990649 Active Cleared 9 Jul 1999

• Rbcfolate Assay for the Technicon Immuno 1 System

  Class II

  FDA 510(k) K954332 Active Cleared 24 Jan 1996

See all devices from Bayer Corp. →