Cleared Traditional

LEGIONELLA PNEUMOPHILA IGG/IGM

K033051 · Trinity Biotech USA · Microbiology
Nov 2003
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K033051 is an FDA 510(k) clearance for the LEGIONELLA PNEUMOPHILA IGG/IGM, a Legionella, Spp., Elisa (Class II — Special Controls, product code MJH), submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on November 26, 2003, 58 days after receiving the submission on September 29, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number K033051 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2003
Decision Date November 26, 2003
Days to Decision 58 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MJH — Legionella, Spp., Elisa
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3300

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