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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 NumberS005
Date Received11/05/2013
Decision Date11/27/2013
Product Code OWE 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
CHANGING THE CONFIGURATION OF THEIR CURRENT LABEL PRINTER, LABEL PRINTING SOFTWARE,AND LABEL INSPECTION SYSTEM FOR THE FOLLOWING FISH ASSAYS: VYSIS ALK BREAK APART FISH PROBE KIT, UROVYSION BLADDER CANCER KIT, AND PATHVYSION HER-2DNA PROBE KIT.
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