FDA 510(k) Application Details - K041619

Device Classification Name Immunoassay Method, Troponin Subunit

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510(K) Number K041619
Device Name Immunoassay Method, Troponin Subunit
Applicant BIOCHECK, INC.
9418 LASAINE AVE.
NORTHRIDGE, CA 91325 US
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Contact ROBIN J HELLEN, M.S.
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Regulation Number 862.1215

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Classification Product Code MMI
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Date Received 06/15/2004
Decision Date 12/17/2004
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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