Cleared Traditional

RHIGENE MESACUP-2 TEST RNP, MODEL M7741

K022017 · Rhigene, Inc. · Immunology
Aug 2002
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K022017 is an FDA 510(k) clearance for the RHIGENE MESACUP-2 TEST RNP, MODEL M7741, 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 August 14, 2002, 55 days after receiving the submission on June 20, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K022017 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2002
Decision Date August 14, 2002
Days to Decision 55 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

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