AESKULISA ENA 6 S— 510(k) K041753

Substantially Equivalent

Aesku Diagnostics

FDA 510(k) clearance K041753 for AESKULISA ENA 6 S, Substantially Equivalent on 2004-07-14. Applicant: Aesku Diagnostics. Device class: 2.

Clearance details

Applicant: Aesku Diagnostics
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2004-06-29
Decision date: 2004-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLL

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 Aesku Diagnostics

K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK2013-12-05
K120889 — AESKUSLIDES ANA HEP-22012-10-15
K091859 — AESKU PR32010-06-03
K091860 — AESKULISA MPO, MODEL 30-7303US2010-02-23
K081251 — MODIFICATION TO AESKULISA DS DNA G2008-05-13

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