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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
Applicant
VYSIS
3100 WOODCREEK DR.
DOWNERS GROVE,  IL  60515
Applicant Contact RUSSEL K ENNS
Correspondent
VYSIS
3100 WOODCREEK DR.
DOWNERS GROVE,  IL  60515
Correspondent Contact RUSSEL K ENNS
Regulation Number866.4700
Classification Product Code
OYU  
Date Received01/31/2001
Decision Date 04/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
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