Cleared Traditional

K820074 - CORTISOL (RIA) KIT
(FDA 510(k) Clearance)

K820074 · Immuno Assay Corp. · Chemistry

Jan 1982

Decision

16d

Days

Class 2

Risk

K820074 is an FDA 510(k) clearance for the CORTISOL (RIA) KIT. This device is classified as a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR).

Submitted by Immuno Assay Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1982, 16 days after receiving the submission on January 12, 1982.

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

Submission Details

510(k) Number	K820074 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 1982
Decision Date	January 28, 1982
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—