Cleared Traditional

CORTISOL ELISA

K062626 · Ibl-Hamburg GmbH · Chemistry

Dec 2006

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K062626 is an FDA 510(k) clearance for the CORTISOL ELISA, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Ibl-Hamburg GmbH (Hamburg, DE). The FDA issued a Cleared decision on December 20, 2006, 106 days after receiving the submission on September 5, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K062626 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 2006
Decision Date	December 20, 2006
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF