Cleared Traditional

RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

K895997 · Lipogen, Inc. · Immunology
Nov 1989
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K895997 is an FDA 510(k) clearance for the RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES, a Anti-rnp Antibody, Antigen And Control (Class II — Special Controls, product code LKO), submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on November 6, 1989, 24 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 K895997 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 1989
Decision Date November 06, 1989
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LKO — Anti-rnp Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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