Cleared Traditional

MESACUP-2 TEST CENP-B

K040200 · Rhigene, Inc. · Immunology
Mar 2004
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K040200 is an FDA 510(k) clearance for the MESACUP-2 TEST CENP-B, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on March 4, 2004, 35 days after receiving the submission on January 29, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K040200 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2004
Decision Date March 04, 2004
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

Similar Devices — LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 111
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
K182353 · Phadia AB · Nov 2018
ImmuLisa Enhanced Centromere Antibody ELISA
K151559 · Immco Diagnostics, Inc. · Mar 2016
ELIA SCL-70S IMMUNOASSAY
K140493 · Phadia GmbH · Oct 2014
QUANTA FLASH CENTROMERE
K123880 · Inova Diagnostics, Inc. · Feb 2014
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
K131330 · Gold Standard Diagnostics · Jan 2014
ANA SCREEN ELISA (IGG)
K131185 · Euroimmun US · Jul 2013