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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 K020950
Device Name SPECTRAL'S 2 IN 1 (TNI-MYO)
Applicant
SPECTRAL DIAGNOSTICS, INC.
135-2 THE WEST MALL
TORONTO, ONTARIO,  CA M9C1C2
Applicant Contact NISAR SHAIKH
Correspondent
SPECTRAL DIAGNOSTICS, INC.
135-2 THE WEST MALL
TORONTO, ONTARIO,  CA M9C1C2
Correspondent Contact NISAR SHAIKH
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Code
DEA  
Date Received03/25/2002
Decision Date 05/24/2002
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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