Cleared Traditional

FIAX TEST FOR ANTI-RUBELLA ANTIBODY

K772219 · Idt, A Division of Whittaker M.A. Bioproducts · Immunology

Jan 1978

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K772219 is an FDA 510(k) clearance for the FIAX TEST FOR ANTI-RUBELLA ANTIBODY, 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 20, 1978, 46 days after receiving the submission on December 5, 1977. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K772219 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 1977
Decision Date	January 20, 1978
Days to Decision	46 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