MESACUP-2 TEST CENP-B— 510(k) K040200

Substantially Equivalent

Rhigene, Inc.

FDA 510(k) clearance K040200 for MESACUP-2 TEST CENP-B, Substantially Equivalent on 2004-03-04. Applicant: Rhigene, Inc.. Device class: 2.

Clearance details

Applicant: Rhigene, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2004-01-29
Decision date: 2004-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJM

K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay2018-11-27
K151559 — ImmuLisa Enhanced Centromere Antibody ELISA2016-03-11
K140493 — ELIA SCL-70S IMMUNOASSAY2014-10-30
K123880 — QUANTA FLASH CENTROMERE2014-02-07
K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT2014-01-28

More clearances from Rhigene, Inc.

K040711 — MESACUP TEST PR-32004-04-02
K040586 — MESACUP TEST MPO, MODEL 110532004-03-22
K033528 — MESACUP-2 TEST JO-1, MODEL 107562003-12-22
K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 107602003-09-26
K022017 — RHIGENE MESACUP-2 TEST RNP, MODEL M77412002-08-14

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