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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 K872755
Device Name KARYOTEC 100
Applicant
Amcor Electronics, Ltd.
Shenkar St., Industrial Zone
Herzeliya,  IL 46725
Applicant Contact EMANUEL MENDES
Correspondent
Amcor Electronics, Ltd.
Shenkar St., Industrial Zone
Herzeliya,  IL 46725
Correspondent Contact EMANUEL MENDES
Regulation Number864.5260
Classification Product Code
LNJ  
Date Received07/13/1987
Decision Date 09/01/1987
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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