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Varelisa Sm Antibodies, Model 18296

by Sweden Diagnostics (Germany) GmbH

510(k) K042629

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042629 Date8 Dec 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LKP
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

Varelisa Sm Antibodies is an enzyme-linked immunosorbent assay (ELISA) designed for the semiquantitative and qualitative determination of SmD antibodies in patient serum or plasma. The device utilizes microtiter plates coated with synthetic SmD peptide as the solid phase to detect specific anti-SmD antibodies.

This device is intended for use in clinical laboratories and has received FDA 510(k) clearance. It is classified under regulation number 866.5100 within the immunology medical specialty.

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