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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 x and y, bmt engraftment
510(k) Number K954214
Device Name CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
Original Applicant
VYSIS
3100 woodcreek dr.
downers grove,  IL  60515
Original Contact vicki anastasi
Regulation Number866.6010
Classification Product Code
OXP  
Subsequent Product Code
KIR  
Date Received09/07/1995
Decision Date 01/21/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Immunology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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