FDA 510(k) Application Details - K173857

Device Classification Name Enzyme Immunoassay, Tracrolimus

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510(K) Number K173857
Device Name Enzyme Immunoassay, Tracrolimus
Applicant Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250 US
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Contact Khoa Tran
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Regulation Number 862.1678

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Classification Product Code MLM
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Date Received 12/20/2017
Decision Date 11/06/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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