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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K951685
Device Name AURAFLEX TESTOSTERONE CALIBRATOR PACK
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 Number862.1680
Classification Product Code
CDZ  
Date Received04/10/1995
Decision Date 11/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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