Cleared Traditional

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES

K895994 · Lipogen, Inc. · Immunology
Oct 1989
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K895994 is an FDA 510(k) clearance for the RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on October 24, 1989, 11 days after receiving the submission on October 13, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K895994 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 1989
Decision Date October 24, 1989
Days to Decision 11 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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