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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K014105
Device Name SPECTRAL'S TROPONIN I
Applicant
SPECTRAL DIAGNOSTICS, INC.
135-2 THE WEST MALL
TORONTO, ONTARIO,  CA M9C1C2
Applicant Contact NISAR A SHAIKH
Correspondent
SPECTRAL DIAGNOSTICS, INC.
135-2 THE WEST MALL
TORONTO, ONTARIO,  CA M9C1C2
Correspondent Contact NISAR A SHAIKH
Regulation Number862.1215
Classification Product Code
MMI  
Date Received12/13/2001
Decision Date 02/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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