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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
510(k) Number K864449
Device Name DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
Applicant
Canadian Bioclinical, Ltd.
81 Finchdene Square,
Scarborough
Ontario Mix 1b4,  CA
Applicant Contact DR. J CLAPP
Correspondent
Canadian Bioclinical, Ltd.
81 Finchdene Square,
Scarborough
Ontario Mix 1b4,  CA
Correspondent Contact DR. J CLAPP
Regulation Number862.3320
Classification Product Code
DPO  
Date Received11/12/1986
Decision Date 02/02/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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