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FDA 510(k), K190675, Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
FDA 510(k), K190675, Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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