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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 K200236
Device Name VITROS BRAHMS PCT Reagent Pack and Calibrators
Applicant
Ortho Clinical Diagnostics
100 Indigo Creek Drive
Rochester,  NY  14626
Applicant Contact Ann M Quinn
Correspondent
Ortho Clinical Diagnostics
100 Indigo Creek Drive
Rochester,  NY  14626
Correspondent Contact Ann M Quinn
Regulation Number866.3215
Classification Product Code
PMT  
Date Received01/30/2020
Decision Date 02/25/2020
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
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