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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 Number
866.4700
Classification Product Code
NTH
Date Received
10/13/2004
Decision Date
12/13/2004
Decision
granted (DENG)
Classification Advisory Committee
Immunology
Review Advisory Committee
Pathology
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Post-NSE
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