FIAX TEST KIT— 510(k) K782041

Name: FDA 510(k) clearance K782041
Creator: U.S. Food and Drug Administration
Published: 1979-01-03

Substantially Equivalent

Idt, A Division of Whittaker M.A. Bioproducts

FDA 510(k) clearance K782041 for FIAX TEST KIT, Substantially Equivalent on 1979-01-03. Applicant: Idt, A Division of Whittaker M.A. Bioproducts. Device class: 2.

Clearance details

Applicant: Idt, A Division of Whittaker M.A. Bioproducts
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1978-12-07
Decision date: 1979-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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