SERAQUEST CMV IGM— 510(k) K982485

Substantially Equivalent

Quest Intl., Inc.

FDA 510(k) clearance K982485 for SERAQUEST CMV IGM, Substantially Equivalent on 1999-01-13. Applicant: Quest Intl., Inc.. Device class: 2.

Clearance details

Applicant: Quest Intl., Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1998-07-17
Decision date: 1999-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

K220949 — Architect CMV IgG2022-10-27
K220911 — Elecsys CMV IgG2022-10-12
K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control2018-07-30
K163569 — Elecsys CMV IgM2017-03-17
K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set2017-01-06

More clearances from Quest Intl., Inc.

K091260 — SERAQUEST EBV EA-D IGG TEST2009-06-08
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

Recalls naming K982485

K-number listed on FDA's recall record

Z-0342-2023 — CMV IgM EIA, in vitro diagnostic.Class II·Ongoing·Bio-Rad Laboratories, Inc.·20221019

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982485.

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