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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 K060818
Device Name ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01
Applicant
BIOKIT S.A.
CAN MALE S/N
LLISSA D'AMUNT
BARCELONA,  ES 08186
Applicant Contact JOAN GUIXER
Correspondent
BIOKIT S.A.
CAN MALE S/N
LLISSA D'AMUNT
BARCELONA,  ES 08186
Correspondent Contact JOAN GUIXER
Regulation Number862.1680
Classification Product Code
CDZ  
Subsequent Product Codes
JIT   JJX  
Date Received03/27/2006
Decision Date 01/23/2007
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
Recalls CDRH Recalls
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