ACTHK-PR RIA KIT— 510(k) K860311

Name: FDA 510(k) clearance K860311
Creator: U.S. Food and Drug Administration
Published: 1986-04-07

Substantially Equivalent

Compagnie Oris Industrie, S.A.

FDA 510(k) clearance K860311 for ACTHK-PR RIA KIT, Substantially Equivalent on 1986-04-07. Applicant: Compagnie Oris Industrie, S.A.. Device class: 2.

Clearance details

Applicant: Compagnie Oris Industrie, S.A.
Product code: Code CKG
Device class: Class 2
Regulation: 21 CFR 862.1025
Advisory panel: Clinical Chemistry
Date received: 1986-01-28
Decision date: 1986-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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