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FDA 510(k) K160729, Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5, by Roche Diagnostics

FDA 510(k) K160729, Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5, by Roche Diagnostics

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510(K) Number: K160729
Device Name: Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
Manufacturer: Roche Diagnostics
Device Classification Name: device to detect and measure procalcitonin (pct) in human clinical specimens
Regulation Number: 866.3215
Classification Product Code: PMT
Date Received: 03/16/2016
Decision Date: 06/13/2016
Regulation Medical Specialty: Microbiology
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