Cleared Traditional

ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER

K944191 · Light Diagnostics · Immunology

Mar 1995

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K944191 is an FDA 510(k) clearance for the ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on March 6, 1995, 189 days after receiving the submission on August 29, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K944191 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 1994
Decision Date	March 06, 1995
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5660