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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name jak2 gene mutation detection test
510(k) Number K172287
Device Name ipsogen JAK2 RGQ PCR Kit
19300 Germantown Road
Germantown,  MD  20874
Applicant Contact Lindsey Howard
QIAGEN Manchester, Ltd.
Skelton House, Lloyd Street North
Manchester,  GB M15 6SH
Correspondent Contact Claire Ryan
Regulation Number866.6070
Classification Product Code
Date Received07/28/2017
Decision Date 01/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No