Cleared Traditional

AXSYM CORTISOL ASSAY

K033731 · Fujirebio Diagnostics,Inc. · Chemistry
Feb 2004
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K033731 is an FDA 510(k) clearance for the AXSYM CORTISOL ASSAY, a Fluorometric, Cortisol (Class II — Special Controls, product code JFT), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on February 20, 2004, 84 days after receiving the submission on November 28, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K033731 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2003
Decision Date February 20, 2004
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFT — Fluorometric, Cortisol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1205

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