Cleared Traditional

FLOUROSET IMMUNOFLUORESCENT ANTIBODY

K823055 · Immulok, Inc. · Immunology

Nov 1982

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K823055 is an FDA 510(k) clearance for the FLOUROSET IMMUNOFLUORESCENT ANTIBODY, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1982, 18 days after receiving the submission on October 18, 1982. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K823055 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 1982
Decision Date	November 05, 1982
Days to Decision	18 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