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510(k) K060818

ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 by Biokit, S.A. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2007
Date Received
March 27, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
Review Panel
CH
Submission Type

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