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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
Applicant
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES,  IL  60018
Applicant Contact NANCY W BENGTSON
Correspondent
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES,  IL  60018
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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