Cleared Traditional

ACS CORTISOL IMMUNOASSAY

K962559 · Ciba Corning Diagnostics Corp. · Chemistry
Nov 1996
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K962559 is an FDA 510(k) clearance for the ACS CORTISOL IMMUNOASSAY, a Fluorometric, Cortisol (Class II — Special Controls, product code JFT), submitted by Ciba Corning Diagnostics Corp. (Irvine, US). The FDA issued a Cleared decision on November 5, 1996, 127 days after receiving the submission on July 1, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K962559 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1996
Decision Date November 05, 1996
Days to Decision 127 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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