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FDA 510(k) Application Details - K030057
Device Classification Name
Immunoassay Method, Troponin Subunit
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510(K) Number
K030057
Device Name
Immunoassay Method, Troponin Subunit
Applicant
SPECTRAL DIAGNOSTICS, INC.
135-2 THE WEST MALL
TORONTO, ONTARIO M9C1C2 CA
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Contact
NISAR A SHAIKH
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
01/07/2003
Decision Date
03/19/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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