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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunochemical, Thyroglobulin Autoantibody
510(k) Number K952607
Device Name AURAFLEX TPO-AB
Applicant
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Applicant Contact C. D KAFADER II
Correspondent
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Correspondent Contact C. D KAFADER II
Regulation Number866.5870
Classification Product Code
JNL  
Date Received05/31/1995
Decision Date 08/25/1995
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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