CORTISOL RADIOIMMUNOASSAY KIT— 510(k) K832638

Name: FDA 510(k) clearance K832638
Creator: U.S. Food and Drug Administration
Published: 1983-09-12

Substantially Equivalent

Bioclinical Group

FDA 510(k) clearance K832638 for CORTISOL RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1983-09-12. Applicant: Bioclinical Group. Device class: 2.

Clearance details

Applicant: Bioclinical Group
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1983-08-04
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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