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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 K122793
Device Name LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET
Applicant
DIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER,  MN  55082 -0285
Applicant Contact JOHN ESKDALE
Correspondent
DIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER,  MN  55082 -0285
Correspondent Contact JOHN ESKDALE
Regulation Number862.1680
Classification Product Code
CDZ  
Subsequent Product Code
JJX  
Date Received09/12/2012
Decision Date 01/25/2013
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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