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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 AND PROBECHEK ALK NEGATIVE CONTROL SLIDES
Classification Namefluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
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 NumberS003
Date Received03/20/2013
Decision Date04/17/2013
Product Code
OWE[ Registered Establishments with 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 
THREE MANUFACTURING CHANGES, INCLUDING THE ADDITION OF A WORKING CELL BANK, IMPLEMENTATION OF A PRE-FERMENTATION OPTICAL DENSITY READING, AND MODIFICATION TO PROPAGATING THE CELL LINE USED TO MAKE NEGATIVE CONTROL SLIDES.
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