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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K153538
Device Name Dextramer CMV Kit
Applicant
Immudex Aps
Fruebjergvej 3
Copenhagen,  DK 2100
Applicant Contact Liselotte Brix
Correspondent
Immudex Aps
Fruebjergvej 3
Copenhagen,  DK 2100
Correspondent Contact Liselotte Brix
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received12/10/2015
Decision Date 03/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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