Cleared Traditional

MESACUP-2 TEST JO-1, MODEL 10756

K033528 · Rhigene, Inc. · Immunology
Dec 2003
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K033528 is an FDA 510(k) clearance for the MESACUP-2 TEST JO-1, MODEL 10756, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Rhigene, Inc. (Westminster, US). The FDA issued a Cleared decision on December 22, 2003, 45 days after receiving the submission on November 7, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K033528 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2003
Decision Date December 22, 2003
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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