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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name procalcitonin assay
510(k) Number K173927
Device Name Elecsys BRAHMS PCT
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact Wes Gerbig
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact Wes Gerbig
Regulation Number866.3215
Classification Product Code
Subsequent Product Codes
Date Received12/26/2017
Decision Date 07/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No