Cleared Traditional

HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G

K062543 · Focus Diagnostics, Inc. · Microbiology

Feb 2007

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K062543 is an FDA 510(k) clearance for the HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G, 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 February 1, 2007, 155 days after receiving the submission on August 30, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K062543 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2006
Decision Date	February 01, 2007
Days to Decision	155 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