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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 K851508
Device Name NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS
Applicant
Nikon, Inc.
623 Stewart Ave.
Garden City,  NY  11530
Applicant Contact ROBERT CHU
Correspondent
Nikon, Inc.
623 Stewart Ave.
Garden City,  NY  11530
Correspondent Contact ROBERT CHU
Regulation Number864.5260
Classification Product Code
LNJ  
Date Received04/15/1985
Decision Date 07/12/1985
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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