FIAX RHEUMATOID FACTOR TEST KIT— 510(k) K812968

Name: FDA 510(k) clearance K812968
Creator: U.S. Food and Drug Administration
Published: 1981-11-06

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K812968 for FIAX RHEUMATOID FACTOR TEST KIT, Substantially Equivalent on 1981-11-06. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1981-10-22
Decision date: 1981-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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