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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
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