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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
Regulation Number864.1890
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP110012
Supplement NumberS023
Date Received01/21/2026
Decision Date02/18/2026
Product Code OWE 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementation of a secondary packaging process
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