Cleared Traditional

ADVIA Centaur Herpes-2 IgG

K181334 · Biokit, S.A. · Microbiology

Aug 2018

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K181334 is an FDA 510(k) clearance for the ADVIA Centaur Herpes-2 IgG, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II — Special Controls, product code MYF), submitted by Biokit, S.A. (Lli?a D'Amunt, ES). The FDA issued a Cleared decision on August 23, 2018, 94 days after receiving the submission on May 21, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K181334 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2018
Decision Date	August 23, 2018
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305