CORTISOL RADIOIMMUNOASSAY KIT— 510(k) K801203

Name: FDA 510(k) clearance K801203
Creator: U.S. Food and Drug Administration
Published: 1980-06-09

Substantially Equivalent

Technia Diagnostics , Ltd.

FDA 510(k) clearance K801203 for CORTISOL RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1980-06-09. Applicant: Technia Diagnostics , Ltd.. Device class: 2.

Clearance details

Applicant: Technia Diagnostics , Ltd.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1980-05-19
Decision date: 1980-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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