FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD— 510(k) K792249

Name: FDA 510(k) clearance K792249
Creator: U.S. Food and Drug Administration
Published: 1980-01-23

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K792249 for FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD, Substantially Equivalent on 1980-01-23. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code GOL
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1979-11-07
Decision date: 1980-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.