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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K870968
Device Name TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
Applicant
Canadian Bioclinical, Ltd.
81 Finchdene Square,
Scarborough
Ontario Mix 1b4,  CA
Applicant Contact JEREMY CLAPP
Correspondent
Canadian Bioclinical, Ltd.
81 Finchdene Square,
Scarborough
Ontario Mix 1b4,  CA
Correspondent Contact JEREMY CLAPP
Regulation Number862.1710
Classification Product Code
CDP  
Date Received03/10/1987
Decision Date 06/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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