Cleared Traditional

K811022 - ANA TEST KIT
(FDA 510(k) Clearance)

K811022 · Immuno-Diagnostic Products, Inc. · Immunology

Apr 1981

Decision

Days

Class 2

Risk

K811022 is an FDA 510(k) clearance for the ANA TEST KIT. This device is classified as a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN).

Submitted by Immuno-Diagnostic Products, Inc.. The FDA issued a Cleared decision on April 23, 1981, 8 days after receiving the submission on April 15, 1981.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K811022 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1981
Decision Date	April 23, 1981
Days to Decision	8 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