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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K944698
Device Name AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
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 Number862.1625
Classification Product Code
CFT  
Date Received09/23/1994
Decision Date 03/21/1995
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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