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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES
Classification Namefluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP110012
Supplement NumberS003
Date Received03/20/2013
Decision Date04/17/2013
Product Code
OWE[ Registered Establishments with OWE ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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