Cleared Traditional

PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K022177 · Bayer Diagnostics Corp. · Immunology

Dec 2002

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K022177 is an FDA 510(k) clearance for the PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 17, 2002, 167 days after receiving the submission on July 3, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K022177 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2002
Decision Date	December 17, 2002
Days to Decision	167 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