RHIGENE MESACUP2 TEST- SCL-70— 510(k) K000750

Substantially Equivalent

Rhigene, Inc.

FDA 510(k) clearance K000750 for RHIGENE MESACUP2 TEST- SCL-70, Substantially Equivalent on 2000-05-09. Applicant: Rhigene, Inc.. Device class: 2.

Clearance details

Applicant: Rhigene, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2000-03-08
Decision date: 2000-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, 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 Rhigene, Inc.

K040711 — MESACUP TEST PR-32004-04-02
K040586 — MESACUP TEST MPO, MODEL 110532004-03-22
K040200 — MESACUP-2 TEST CENP-B2004-03-04
K033528 — MESACUP-2 TEST JO-1, MODEL 107562003-12-22
K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 107602003-09-26

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