Cleared Traditional

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

K022288 · Bayer Corp. · Immunology

Dec 2002

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K022288 is an FDA 510(k) clearance for the COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 17, 2002, 155 days after receiving the submission on July 15, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K022288 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2002
Decision Date	December 17, 2002
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	LTJ — Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6010