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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 K181002
Device Name Atellica IM BRAHMS Procalcitonin (PCT)
Applicant
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
tarrytown,  NY  10591 -5097
Applicant Contact fatima pacheco
Correspondent
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
tarrytown,  NY  10591 -5097
Correspondent Contact fatima pacheco
Regulation Number866.3215
Classification Product Code
PMT  
Date Received04/16/2018
Decision Date 07/16/2018
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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