FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT— 510(k) K853067

Name: FDA 510(k) clearance K853067
Creator: U.S. Food and Drug Administration
Published: 1985-10-22

Substantially Equivalent

Idt, A Division of Whittaker M.A. Bioproducts

FDA 510(k) clearance K853067 for FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT, Substantially Equivalent on 1985-10-22. Applicant: Idt, A Division of Whittaker M.A. Bioproducts. Device class: 1.

Clearance details

Applicant: Idt, A Division of Whittaker M.A. Bioproducts
Product code: Code GRE
Device class: Class 1
Regulation: 21 CFR 866.3520
Advisory panel: Microbiology
Date received: 1985-07-22
Decision date: 1985-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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