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FDA 510(k) K171566, Atellica IM High-Sensitivity Troponin I (TNIH), by Siemens Healthcare Diagnostics, Inc.

FDA 510(k) K171566, Atellica IM High-Sensitivity Troponin I (TNIH), by Siemens Healthcare Diagnostics, Inc.

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510(K) Number: K171566
Device Name: Atellica IM High-Sensitivity Troponin I (TNIH)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Device Classification Name: immunoassay method, troponin subunit
Regulation Number: 862.1215
Classification Product Code: MMI
Date Received: 05/30/2017
Decision Date: 07/19/2018
Regulation Medical Specialty: Clinical Chemistry

665 pages (2,629 of 3,294 original pages are fully redacted)
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