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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
Generic NameFluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
ApplicantABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018
PMA NumberP110012
Supplement NumberS007
Date Received08/14/2014
Decision Date12/10/2014
Product Code OWE 
Advisory Committee Pathology
Clinical TrialsNCT00585195
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE PROBECHK ALK POSITIVE AND NEGATIVE CONTROL SLIDE LABELING, AND EXPANSION OF THE ASSAY GUARD BAND PARAMETERS.
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