Cleared Traditional

FIAX TEST KIT

K782041 · Idt, A Division of Whittaker M.A. Bioproducts · Immunology

Jan 1979

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K782041 is an FDA 510(k) clearance for the FIAX TEST KIT, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Idt, A Division of Whittaker M.A. Bioproducts (Mchenry, US). The FDA issued a Cleared decision on January 3, 1979, 27 days after receiving the submission on December 7, 1978. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K782041 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 07, 1978
Decision Date	January 03, 1979
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—

Device Classification

Product Code	DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5100