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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Thyroid Autoantibody
510(k) Number K925194
Device Name THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT
Applicant
Joldon Diagnostics
81 Finchdene Sq.
Scarborough, Ontario,  CA M1X 1B4
Applicant Contact TUY T NGUYEN
Correspondent
Joldon Diagnostics
81 Finchdene Sq.
Scarborough, Ontario,  CA M1X 1B4
Correspondent Contact TUY T NGUYEN
Regulation Number866.5870
Classification Product Code
JZO  
Date Received10/15/1992
Decision Date 02/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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