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510(k) K190675

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay by Siemens Healthcare Diagnostics, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2019
Date Received
March 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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Other clearances for product code MMI

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