SeraQuest HSV Type 2 Specific IgG— 510(k) K181514

Name: FDA 510(k) clearance K181514
Creator: U.S. Food and Drug Administration
Published: 2019-06-13

Substantially Equivalent

Quest International, Inc.

FDA 510(k) clearance K181514 for SeraQuest HSV Type 2 Specific IgG, Substantially Equivalent on 2019-06-13. Applicant: Quest International, Inc.. Device class: 2.

Clearance details

Applicant: Quest International, Inc.
Product code: Code MYF
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2018-06-08
Decision date: 2019-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm City, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MYF

view all

K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls2025-02-12
K220924 — Elecsys HSV-2 IgG (08948887160)2022-10-12
K181334 — ADVIA Centaur Herpes-2 IgG2018-08-23
K152353 — SeraQuest HSV Type 2 Specific IgG2016-05-13
K103603 — ZEUS ELISA HSV GG-2 IGG TEST SYSTEM2011-05-20

More clearances from Quest International, Inc.

view all

K162276 — SeraQuest Herpes Type 1 Specific IgG2016-10-01

Adverse events under product code MYF

product code MYF

Injury: 316
Other: 1
Total: 317

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.