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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Free Thyroxine
510(k) Number K944697
Device Name AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
Applicant
Organon Teknika Corp.
Treyburn 100 Akzo Ave.
Durham,  NC  27704
Applicant Contact C D KAFADER II
Correspondent
Organon Teknika Corp.
Treyburn 100 Akzo Ave.
Durham,  NC  27704
Correspondent Contact C D KAFADER II
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Code
JIS  
Date Received09/23/1994
Decision Date 02/22/1995
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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