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FDA 510(k) Application Details - K053020
Device Classification Name
Immunoassay Method, Troponin Subunit
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510(K) Number
K053020
Device Name
Immunoassay Method, Troponin Subunit
Applicant
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
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Contact
ANDRES HOLLE
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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
10/26/2005
Decision Date
12/30/2005
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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