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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K160590
Device Name XN CHECK
Applicant
Streck
7002 S 109th St.
La Vista,  NE  68128
Applicant Contact DEBORAH KIPP
Correspondent
Streck
7002 S 109th St.
La Vista,  NE  68128
Correspondent Contact DEBORAH KIPP
Regulation Number864.8625
Classification Product Code
JPK  
Date Received03/01/2016
Decision Date 12/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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