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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chromosome, Automated
510(k) Number K895095
Device Name AKS II
Applicant
Amoco Technology Co.
Amoco Research Center
P.O. Box 400
Naperville,  IL  60566
Applicant Contact MARIANNE URBAUER
Correspondent
Amoco Technology Co.
Amoco Research Center
P.O. Box 400
Naperville,  IL  60566
Correspondent Contact MARIANNE URBAUER
Regulation Number864.5260
Classification Product Code
LNJ  
Date Received08/14/1989
Decision Date 02/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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