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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-probe kit, human chromosome
510(k) Number K010288
Device Name ANEUVYSION MULITICOLOR DNA PROBE KIT
Original Applicant
VYSIS
3100 woodcreek dr.
downers grove,  IL  60515
Original Contact russel k enns
Regulation Number866.4700
Classification Product Code
OYU  
Date Received01/31/2001
Decision Date 04/13/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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