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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chronic Lymphocytic Leukemia Fish Probe Kit
510(k) Number K100015
Device Name VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
Applicant
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES,  IL  60018
Applicant Contact PAMELA L SWATKOWSKI
Correspondent
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES,  IL  60018
Correspondent Contact PAMELA L SWATKOWSKI
Regulation Number866.6040
Classification Product Code
OVQ  
Date Received01/04/2010
Decision Date 08/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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