FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY— 510(k) K853540

Name: FDA 510(k) clearance K853540
Creator: U.S. Food and Drug Administration
Published: 1986-02-04

Substantially Equivalent

Idt, A Division of Whittaker M.A. Bioproducts

FDA 510(k) clearance K853540 for FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY, Substantially Equivalent on 1986-02-04. 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 GQX
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1985-08-23
Decision date: 1986-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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