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FDA 510(k) Application Details - K082699
Device Classification Name
Immunoassay Method, Troponin Subunit
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510(K) Number
K082699
Device Name
Immunoassay Method, Troponin Subunit
Applicant
Roche Diagnostics
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
JANE PHILLIPS
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
09/15/2008
Decision Date
08/19/2009
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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