FDA 510(k), K171566, Atellica IM High-Sensitivity Troponin I (TNIH)

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)