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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 K173683
Device Name LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
Applicant
DiaSorin Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082 -0285
Applicant Contact John C Walter
Correspondent
DiaSorin Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082 -0285
Correspondent Contact Carol A DePouw
Regulation Number866.3215
Classification Product Code
PRI  
Subsequent Product Codes
JJX   NTM   PMT  
Date Received12/01/2017
Decision Date 02/27/2018
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
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