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Device | UROVYSION BLADDER CANCER KIT |
Generic Name | Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence |
Applicant | ABBOTT MOLECULAR 1300 E. Touhy Avenue Des Plaines, IL 60018 |
PMA Number | P030052 |
Supplement Number | S012 |
Date Received | 08/29/2013 |
Decision Date | 01/24/2014 |
Product Code |
NSD |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT LEICA BIOSYSTEMS IN SOLON MILLS, ILLINOIS. |