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Modified Access R-Clone ANA/RF Screening Test

by Lipogen, Inc.

510(k) K892421

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK892421 Date9 May 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LJM
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Modified Access R-Clone ANA/RF Screening Test is an Antinuclear Antibody (Enzyme-Labeled) Antigen device, classified under Immunology. It is designed to detect autoimmune antibodies in serum, body fluids, or tissues that bind to nuclear constituents such as RNA, DNA, or related molecules using immunochemical techniques.

This in vitro diagnostic device is supplied as a reagent-based assay system and is intended for single-use in clinical laboratory settings. It has received FDA 510(k) clearance under the Traditional pathway, with a decision classification of Substantially Equivalent (SESE). No specific sterility or MRI safety information is provided, and the device is regulated under 21 CFR 866.5100 for immunology-related diagnostics.

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