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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 K041866
Device Name ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE, SCOTLAND,  GB DD2 1XA
Applicant Contact SUSAN LEONARD
Correspondent
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE, SCOTLAND,  GB DD2 1XA
Correspondent Contact SUSAN LEONARD
Regulation Number862.1680
Classification Product Code
CDZ  
Subsequent Product Code
JIS  
Date Received07/09/2004
Decision Date 09/29/2004
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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