Cleared Abbreviated

UROVYSION BLADDER CANCER RECURRENCE KIT

K013785 · Vysis · Immunology
Feb 2002
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K013785 is an FDA 510(k) clearance for the 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 February 8, 2002, 86 days after receiving the submission on November 14, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K013785 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2001
Decision Date February 08, 2002
Days to Decision 86 days
Submission Type Abbreviated
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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