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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 K864955
Device Name CYTOSCAN
Applicant
Image Recognition Systems , Ltd.
720 Birchwood Blvd., Birchwood
Warrington, Cheshire,  GB WA3 7PX
Applicant Contact JOHN T STOPFORD
Correspondent
Image Recognition Systems , Ltd.
720 Birchwood Blvd., Birchwood
Warrington, Cheshire,  GB WA3 7PX
Correspondent Contact JOHN T STOPFORD
Regulation Number864.5260
Classification Product Code
LNJ  
Date Received12/18/1986
Decision Date 03/16/1987
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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