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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 K843343
Device Name MEDICA IIF-ANTI-THYROID ANTIBODY TEST
Applicant
Medical Diagnostics, Ca.
2382 Camino Vida Roble
Suite I
Calsbad,  CA  92008
Applicant Contact PAUL BARTL
Correspondent
Medical Diagnostics, Ca.
2382 Camino Vida Roble
Suite I
Calsbad,  CA  92008
Correspondent Contact PAUL BARTL
Regulation Number866.5870
Classification Product Code
JZO  
Date Received08/27/1984
Decision Date 10/22/1984
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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