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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K972408
Device Name CARDIAC STATUS CONTROLS
Applicant
Spectral Diagnostics, Inc.
135-2 The W. Mall
Toronto, Ontario,  CA M9C 1C2
Applicant Contact FRANCEE S BOCHES
Correspondent
Spectral Diagnostics, Inc.
135-2 The W. Mall
Toronto, Ontario,  CA M9C 1C2
Correspondent Contact FRANCEE S BOCHES
Regulation Number862.1660
Classification Product Code
JJT  
Date Received06/26/1997
Decision Date 07/25/1997
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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