Cleared Traditional

PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G

K073382 · Focus Diagnostics, Inc. · Microbiology
Jul 2008
Decision
238d
Days
Class 1
Risk

About This 510(k) Submission

K073382 is an FDA 510(k) clearance for the PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on July 28, 2008, 238 days after receiving the submission on December 3, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K073382 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2007
Decision Date July 28, 2008
Days to Decision 238 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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