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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
Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP110012
Supplement NumberS002
Date Received11/15/2012
Decision Date12/26/2012
Product Code OWE 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEAD MIXING SYSTEM AND VALIDATE THE MIXING PROCESS IN THE MANUFACTURE OF THE HYBRIDIZATION BUFFER, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.
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