Cleared Special

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST

K033982 · Vysis · Immunology
Jan 2004
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K033982 is an FDA 510(k) clearance for the MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST, a System, Test, Tumor Marker, Monitoring, Bladder (Class II — Special Controls, product code MMW), submitted by Vysis (Downers Grove, US). The FDA issued a Cleared decision on January 22, 2004, 30 days after receiving the submission on December 23, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K033982 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2003
Decision Date January 22, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MMW — System, Test, Tumor Marker, Monitoring, Bladder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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