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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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