Cleared Traditional

RHIGENE MESACUP2 TEST- RNP

K000752 · Rhigene, Inc. · Immunology
May 2000
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K000752 is an FDA 510(k) clearance for the RHIGENE MESACUP2 TEST- RNP, a Anti-rnp Antibody, Antigen And Control (Class II — Special Controls, product code LKO), submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 9, 2000, 62 days after receiving the submission on March 8, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K000752 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2000
Decision Date May 09, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LKO — Anti-rnp Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

Similar Devices — LKO Anti-rnp Antibody, Antigen And Control

All 22
Maverick RNP Assay and Maverick Diagnostic System
K191085 · Genalyte, Inc. · Oct 2019
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
K140224 · Euroimmun US · Dec 2014
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
K123261 · Euroimmun US · Jun 2013
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
K083117 · Phadia US, Inc. · May 2009
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
K071210 · Biomedical Diagnostics (Bmd) SA · Dec 2007
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
K022017 · Rhigene, Inc. · Aug 2002