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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
510(k) Number K132978
Device Name IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST
Applicant
Sequenom, Inc.
3595 John Hopkins Ct.
San Diego,  CA  92121
Applicant Contact Robin Weiner
Correspondent
Sequenom, Inc.
3595 John Hopkins Ct.
San Diego,  CA  92121
Correspondent Contact Robin Weiner
Regulation Number864.7280
Classification Product Code
PHJ  
Date Received09/23/2013
Decision Date 06/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
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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