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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
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