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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K982679
Device Name MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST
Applicant
Spectral Diagnostics, Inc.
135-2 The W. Mall
Toronto, Ontario,  CA M9C 1C2
Applicant Contact JOSEPH LAURINE
Correspondent
Spectral Diagnostics, Inc.
135-2 The W. Mall
Toronto, Ontario,  CA M9C 1C2
Correspondent Contact JOSEPH LAURINE
Regulation Number866.5680
Classification Product Code
DDR  
Date Received07/31/1998
Decision Date 10/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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