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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 K152185
Device Name ARCHITECT SHBG
Applicant
BIOKIT, S.A.
CAN MALE, S/N
LLICA D AMUNT,  ES 08186
Applicant Contact ANGELS ROMA
Correspondent
BIOKIT, S.A.
CAN MALE, S/N
LLICA D AMUNT,  ES 08186
Correspondent Contact ANGELS ROMA
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received08/05/2015
Decision Date 02/11/2016
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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