Cleared Traditional

ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01

K060818 · Biokit, S.A. · Chemistry
Jan 2007
Decision
302d
Days
Class 1
Risk

About This 510(k) Submission

K060818 is an FDA 510(k) clearance for the ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on January 23, 2007, 302 days after receiving the submission on March 27, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K060818 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2006
Decision Date January 23, 2007
Days to Decision 302 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1680