510(k) clearance

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La

FDA 510(k) source

510(k) number

K253817

Applicant

Immunodiagnostics Systems Limited

Decision date

Aug 21, 2026

Date received

Nov 28, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LLL

Device type

Extractable Antinuclear Antibody, Antigen And Control

Device class

Class II

Regulation

21 CFR 866.5100

Advisory committee

Immunology

Statement or summary

Summary

Third party

N

Location

Boldon, GB