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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 K120009
Device Name TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Dept 9v6, Ap5n-2
Abbott Park,  IL  60064
Applicant Contact JOHN RIZOS
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Dept 9v6, Ap5n-2
Abbott Park,  IL  60064
Correspondent Contact JOHN RIZOS
Regulation Number862.1680
Classification Product Code
CDZ  
Subsequent Product Codes
JIT   JJX  
Date Received01/03/2012
Decision Date 09/11/2012
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
Predetermined Change
Control Plan Authorized		 No
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