Cleared Traditional

ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

K060027 · Biokit, S.A. · Chemistry
Jan 2006
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K060027 is an FDA 510(k) clearance for the ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH), a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on January 26, 2006, 22 days after receiving the submission on January 4, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K060027 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2006
Decision Date January 26, 2006
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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