
Siemens Healthcare Diagnostics, Inc.
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Dimension EXL High-Sensitivity Troponin I (TNIH) Assay is an FDA 510(k)-cleared medical device (K190675) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 2019. Regulation: 8.