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FDA 510(k) Application Details - K060875
Device Classification Name
Immunoassay Method, Troponin Subunit
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510(K) Number
K060875
Device Name
Immunoassay Method, Troponin Subunit
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-3500 US
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Contact
MARGARET PROCHNIAK
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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
03/30/2006
Decision Date
06/14/2006
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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