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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays
De Novo Number DEN040010
510(K) Number K041875
Device Name VYSIS AUTOVYSION SYSTEM
Requester
VYSIS
3100 woodcreek dr.
downers grove,  IL  60515
Contact lynda hague
Regulation Number866.4700
Classification Product Code
NTH  
Date Received10/13/2004
Decision Date 12/13/2004
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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