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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 K192815
Device Name Elecsys BRAHMS PCT
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Wes Gerbig
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Wes Gerbig
Regulation Number866.3215
Classification Product Code
PRI  
Date Received10/01/2019
Decision Date 03/09/2020
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
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