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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name immunoassay method, troponin subunit
510(k) Number K190675
Device Name Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
Applicant
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive
newark,  DE  19714
Applicant Contact laura j. duggan
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive
newark,  DE  19714
Correspondent Contact laura j. duggan
Regulation Number862.1215
Classification Product Code
MMI  
Date Received03/15/2019
Decision Date 05/17/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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