FDA 510(k) Application Details - K171566

Device Classification Name Immunoassay Method, Troponin Subunit

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510(K) Number K171566
Device Name Immunoassay Method, Troponin Subunit
Applicant Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 US
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Contact Matthew Gee
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Regulation Number 862.1215

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Classification Product Code MMI
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Date Received 05/30/2017
Decision Date 07/19/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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