Cleared Traditional

K822892 - CORTISOL RIA KIT
(FDA 510(k) Clearance)

K822892 · Antibodies, Inc. · Chemistry

Nov 1982

Decision

34d

Days

Class 2

Risk

K822892 is an FDA 510(k) clearance for the CORTISOL RIA KIT, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1982, 34 days after receiving the submission on September 28, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K822892 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 1982
Decision Date	November 01, 1982
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—