ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN— 510(k) K840867

Name: FDA 510(k) clearance K840867
Creator: U.S. Food and Drug Administration
Published: 1984-05-11

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K840867 for ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN, Substantially Equivalent on 1984-05-11. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code DEI
Device class: Class 2
Regulation: 21 CFR 866.5130
Advisory panel: Immunology
Date received: 1984-02-27
Decision date: 1984-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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