Cleared Traditional

SeraQuest Herpes Type 1 Specific IgG

K162276 · Quest International, Inc. · Microbiology

Oct 2016

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K162276 is an FDA 510(k) clearance for the SeraQuest Herpes Type 1 Specific IgG, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II — Special Controls, product code MXJ), submitted by Quest International, Inc. (Mami, US). The FDA issued a Cleared decision on October 1, 2016, 50 days after receiving the submission on August 12, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K162276 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2016
Decision Date	October 01, 2016
Days to Decision	50 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