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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 W. Mall
Toronto, Ontario,  CA M9C 1C2
Applicant Contact NISAR A SHAIKH
Correspondent
Spectral Diagnostics, Inc.
135-2 The W. Mall
Toronto, Ontario,  CA M9C 1C2
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
Predetermined Change
Control Plan Authorized		 No
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