TDX TRANSFERRIN DIAGNOSTIC KIT— 510(k) K854416

Name: FDA 510(k) clearance K854416
Creator: U.S. Food and Drug Administration
Published: 1986-02-21

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K854416 for TDX TRANSFERRIN DIAGNOSTIC KIT, Substantially Equivalent on 1986-02-21. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 1985-11-04
Decision date: 1986-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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