PMA P030052S022

Device

UroVysion Bladder Cancer Kit

Applicant

Abbott Molecular

PMA number

P030052

Supplement

S022

Product code

NSD

Decision date

2018-03-12

Classification

Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence

Generic name

Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence

Approval order statement

Changes to the manufacturing process and manufacturing site of a suppliers product.

Summary

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