Cleared Traditional

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

K011031 · Vysis · Immunology
Aug 2001
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K011031 is an FDA 510(k) clearance for the VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT, 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 August 3, 2001, 120 days after receiving the submission on April 5, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K011031 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2001
Decision Date August 03, 2001
Days to Decision 120 days
Submission Type Traditional
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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