OCTEIA IGF-1 KIT— 510(k) K950510

Name: FDA 510(k) clearance K950510
Creator: U.S. Food and Drug Administration
Published: 1995-04-05

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K950510 for OCTEIA IGF-1 KIT, Substantially Equivalent on 1995-04-05. Applicant: Immunodiagnostic Systems , Ltd.. Device class: 1.

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1995-02-06
Decision date: 1995-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyne And Wear, GB

Download summary PDF View on FDA.gov ↗

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