FDA 510(k), K190675, Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
FDA 510(k), K190675, Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
510(K) Number: K190675
Device Name: Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Device Classification Name: immunoassay method, troponin subunit
Regulation Number: 862.1215
Classification Product Code: MMI
Date Received: 03/15/2019
Decision Date: 05/17/2019
Regulation Medical Specialty: Clinical Chemistry
Total pages: 2442
Fully redacted pages: 1255
Content pages: 1187
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