TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT— 510(k) K852589

Name: FDA 510(k) clearance K852589
Creator: U.S. Food and Drug Administration
Published: 1985-07-15

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K852589 for TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT, Substantially Equivalent on 1985-07-15. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1985-06-18
Decision date: 1985-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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