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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 K851174
Device Name METACHROME
Applicant
Potomac Medical System
P.O. Box 4212
Silver Spring,  MD  20904
Applicant Contact ROBERT S LEDLEY
Correspondent
Potomac Medical System
P.O. Box 4212
Silver Spring,  MD  20904
Correspondent Contact ROBERT S LEDLEY
Regulation Number864.5260
Classification Product Code
LNJ  
Date Received03/25/1985
Decision Date 05/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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