Cleared Traditional

CRITHIDNA ANTI-DNA TEST KIT

K812314 · Antibodies, Inc. · Immunology

Sep 1981

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K812314 is an FDA 510(k) clearance for the CRITHIDNA ANTI-DNA TEST KIT, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1981, 15 days after receiving the submission on August 17, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K812314 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 1981
Decision Date	September 01, 1981
Days to Decision	15 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