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FDA 510(k) Application Details - K190675
Device Classification Name
Immunoassay Method, Troponin Subunit
More FDA Info for this Device
510(K) Number
K190675
Device Name
Immunoassay Method, Troponin Subunit
Applicant
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive
Newark, DE 19714 US
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Contact
Laura J. Duggan
Other 510(k) Applications for this Contact
Regulation Number
862.1215
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Classification Product Code
MMI
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More FDA Info for this Product Code
Date Received
03/15/2019
Decision Date
05/17/2019
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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