Cleared Traditional

K943427 - ACE CEDIA CORTISOL ASSAY
(FDA 510(k) Clearance)

K943427 · Schiapparelli Biosystems, Inc. · Chemistry

Nov 1994

Decision

136d

Days

Class 2

Risk

K943427 is an FDA 510(k) clearance for the ACE CEDIA CORTISOL ASSAY. This device is classified as a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR).

Submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on November 28, 1994, 136 days after receiving the submission on July 15, 1994.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K943427 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 1994
Decision Date	November 28, 1994
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF