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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,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT
Classification Namefluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP110012
Supplement NumberS009
Date Received10/03/2014
Decision Date07/02/2015
Product Code
OWE[ Registered Establishments with OWE ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for use of abbott vp 2000 processor and a corresponding set of reagents in an automated slide processing procedure.
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