Cleared Traditional

K071511 - PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
(FDA 510(k) Clearance)

K071511 · Focus Diagnostics, Inc. · Microbiology
Oct 2007
Decision
123d
Days
Class 2
Risk

K071511 is an FDA 510(k) clearance for the PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G. This device is classified as a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II — Special Controls, product code MXJ).

Submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on October 5, 2007, 123 days after receiving the submission on June 4, 2007.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K071511 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2007
Decision Date October 05, 2007
Days to Decision 123 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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