Cleared Traditional

PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M

K073381 · Focus Diagnostics, Inc. · Microbiology
Aug 2008
Decision
245d
Days
Class 1
Risk

About This 510(k) Submission

K073381 is an FDA 510(k) clearance for the PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M, a Antibody Igm, If, Epstein-barr Virus (Class I — General Controls, product code LJN), submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on August 4, 2008, 245 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 K073381 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2007
Decision Date August 04, 2008
Days to Decision 245 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJN — Antibody Igm, If, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235