Cleared Traditional

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY

K990915 · Stellar Bio Systems, Inc. · Immunology

Apr 1999

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K990915 is an FDA 510(k) clearance for the INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on April 21, 1999, 34 days after receiving the submission on March 18, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K990915 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 1999
Decision Date	April 21, 1999
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5100