SERAQUEST EBV EA-D IGG TEST— 510(k) K091260

Substantially Equivalent

Quest Intl., Inc.

FDA 510(k) clearance K091260 for SERAQUEST EBV EA-D IGG TEST, Substantially Equivalent on 2009-06-08. Applicant: Quest Intl., Inc.. Device class: 1.

Clearance details

Applicant: Quest Intl., Inc.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 2009-04-29
Decision date: 2009-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LSE

K260221 — Elecsys EBV EBNA IgG2026-10-02
K260232 — Elecsys EBV VCA IgG2026-10-02
K233606 — ADVIA Centaur EBV-VCA IgM2024-08-07
K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set2017-01-05
K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set2017-01-04

More clearances from Quest Intl., Inc.

K033915 — MODIFICATION TO SERAQUEST EB VCA IGG2004-01-16
K033780 — MODIFICATION TO SERAQUEST VCA IGM2004-01-15
K023593 — SERAQUEST ANTI-THYROID PEROXIDASE (TPO)2003-02-06
K023592 — SERAQUEST ANTI-THYROGLOBULIN2003-01-06
K003069 — ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM2000-11-27

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