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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
Applicant
VYSIS
3100 WOODCREEK DR.
DOWNERS GROVE,  IL  60515
Applicant Contact VICKI ANASTASI
Correspondent
VYSIS
3100 WOODCREEK DR.
DOWNERS GROVE,  IL  60515
Correspondent 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 (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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