Cleared Traditional

SeraQuest HSV Type 2 Specific IgG

K181514 · Quest International, Inc. · Microbiology

Jun 2019

Decision

370d

Days

Class 2

Risk

About This 510(k) Submission

K181514 is an FDA 510(k) clearance for the SeraQuest HSV Type 2 Specific IgG, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II — Special Controls, product code MYF), submitted by Quest International, Inc. (Palm City, US). The FDA issued a Cleared decision on June 13, 2019, 370 days after receiving the submission on June 8, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K181514 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2018
Decision Date	June 13, 2019
Days to Decision	370 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