ALDOSTERONE DIRECT RIA KIT— 510(k) K854876

Name: FDA 510(k) clearance K854876
Creator: U.S. Food and Drug Administration
Published: 1986-03-17

Substantially Equivalent

Biotecx Laboratories, Inc.

FDA 510(k) clearance K854876 for ALDOSTERONE DIRECT RIA KIT, Substantially Equivalent on 1986-03-17. Applicant: Biotecx Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Biotecx Laboratories, Inc.
Product code: Code KQN
Device class: Class 2
Regulation: 21 CFR 862.1090
Advisory panel: Clinical Chemistry
Date received: 1985-12-06
Decision date: 1986-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Friendswood, TX, US

Download summary PDF View on FDA.gov ↗

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