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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 K152155
Device Name ARCHITECT 2nd Generation Testosterone
Applicant
Abbott Laboratories
100 Abbott Park Rd, Dept. 093G, Bldg. AP8-1
Abbott Park,  IL  60064
Applicant Contact Regina Xavier Kumar
Correspondent
Abbott Laboratories
100 Abbott Park Rd, Dept. 093G, Bldg. AP8-1
Abbott Park,  IL  60064
Correspondent Contact Regina Xavier Kumar
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received08/03/2015
Decision Date 12/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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