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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
510(k) Number K160729
FOIA Releasable 510(k) K160729
Device Name Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact Adam Clark
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact Adam Clark
Regulation Number866.3215
Classification Product Code
PMT  
Subsequent Product Code
JJX  
Date Received03/16/2016
Decision Date 06/13/2016
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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