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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 NumberS013
Date Received11/22/2016
Decision Date04/12/2017
Product Code OWE 
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for upgrades to the VP 2000 Processor.
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