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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K152117
Device Name Dropper hsCRP High Sensitivity CRP Control
Applicant
Quantimetrix Corporation
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Applicant Contact Kaylna Snylyk
Correspondent
Quantimetrix Corporation
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Correspondent Contact Kaylna Snylyk
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/30/2015
Decision Date 04/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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