Cleared Traditional

GAMMA STICK CORTISOL RIA KIT/STICK KIT

K800538 · Alpha Gamma Laboratory · Chemistry

Apr 1980

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K800538 is an FDA 510(k) clearance for the GAMMA STICK CORTISOL RIA KIT/STICK KIT, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Alpha Gamma Laboratory (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980, 45 days after receiving the submission on March 10, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K800538 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 1980
Decision Date	April 24, 1980
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—