ANTI-DSDNA ANTIBODY TEST— 510(k) K913041

Name: FDA 510(k) clearance K913041
Creator: U.S. Food and Drug Administration
Published: 1991-11-05

Substantially Equivalent

Helix Diagnostics, Inc.

FDA 510(k) clearance K913041 for ANTI-DSDNA ANTIBODY TEST, Substantially Equivalent on 1991-11-05. Applicant: Helix Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Helix Diagnostics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1991-07-09
Decision date: 1991-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLL

view all

K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La2026-08-21
K253367 — EliA CTD 13 Screen2026-06-25
K250666 — Alegria Flash CTD Screen2025-10-22
K250408 — Alegria Flash ENA Screen2025-09-19
K213403 — Aptiva CTD Essential Reagent2023-09-29

More clearances from Helix Diagnostics, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.