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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna fish probe kit for specimen characterization, human chromosome, hematological disorders
510(k) Number K131508
Device Name VYSIS D7S486/CEP 7 FISH PROBE KIT
Original Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines,  IL  60018
Original Contact nancy w bengtson
Regulation Number864.1870
Classification Product Code
PFG  
Date Received05/24/2013
Decision Date 09/13/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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