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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT
Generic NameFluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
ApplicantABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018
PMA NumberP110012
Supplement NumberS009
Date Received10/01/2014
Decision Date07/02/2015
Product Code OWE 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR USE OF ABBOTT VP 2000 PROCESSOR AND A CORRESPONDING SET OFREAGENTS IN AN AUTOMATED SLIDE PROCESSING PROCEDURE.
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