Cleared Traditional

ARCHITECT CORTISOL ASSAY

K062204 · Seradyn, Inc. · Chemistry
Sep 2006
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K062204 is an FDA 510(k) clearance for the ARCHITECT CORTISOL ASSAY, a Fluorometric, Cortisol (Class II — Special Controls, product code JFT), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 22, 2006, 52 days after receiving the submission on August 1, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K062204 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2006
Decision Date September 22, 2006
Days to Decision 52 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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