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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K981474
Device Name CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
Applicant
Spectral Diagnostics, Inc.
135-2 The W. Mall
Toronto, Ontario,  CA M9C 1C2
Applicant Contact JOSEPH LAURINO
Correspondent
Spectral Diagnostics, Inc.
135-2 The W. Mall
Toronto, Ontario,  CA M9C 1C2
Correspondent Contact JOSEPH LAURINO
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/24/1998
Decision Date 05/07/1998
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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