TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT— 510(k) K854944

Name: FDA 510(k) clearance K854944
Creator: U.S. Food and Drug Administration
Published: 1986-08-27

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K854944 for TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT, Substantially Equivalent on 1986-08-27. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DAH
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1985-12-10
Decision date: 1986-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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