Cleared Traditional

SERAQUEST EB VCA IGG

K990410 · Quest Intl., Inc. · Microbiology
Oct 1999
Decision
261d
Days
Class 1
Risk

About This 510(k) Submission

K990410 is an FDA 510(k) clearance for the SERAQUEST EB VCA IGG, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on October 28, 1999, 261 days after receiving the submission on February 9, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K990410 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1999
Decision Date October 28, 1999
Days to Decision 261 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

Similar Devices — LSE Epstein-barr Virus, Other

All 55
ADVIA Centaur EBV-VCA IgM
K233606 · Biokit, S.A. · Aug 2024
LIAISON? VCA IgG and LIAISON? VCA IgG Serum Control Set; LIAISON? EBNA IgG and LIAISON? EBNA IgG Serum Control Set
K162961 · DiaSorin, Inc. · Jan 2017
LIAISON? EA IgG and LIAISON? EA IgG Serum Control Set
K162959 · DiaSorin, Inc. · Jan 2017
SERAQUEST EBV EA-D IGG TEST
K091260 · Quest Intl., Inc. · Jun 2009
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
K073382 · Focus Diagnostics, Inc. · Jul 2008
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062211 · Bio-Rad Laboratories, Inc. · Dec 2006