SERAQUEST TOXOPLASMA IGM— 510(k) K971672

Name: FDA 510(k) clearance K971672
Creator: U.S. Food and Drug Administration
Published: 1997-10-21

Substantially Equivalent

Quest Intl., Inc.

FDA 510(k) clearance K971672 for SERAQUEST TOXOPLASMA IGM, Substantially Equivalent on 1997-10-21. Applicant: Quest Intl., Inc.. Device class: 2.

Clearance details

Applicant: Quest Intl., Inc.
Product code: Code LGD
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1997-05-07
Decision date: 1997-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGD

view all

K242022 — Access Toxo IgG2025-03-28
K242095 — Access Toxo IgM II2024-10-11
K233932 — Alinity i Toxo IgM2024-08-30
K210596 — ARCHITECT Toxo IgG2022-05-19
K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl2017-06-23

More clearances from Quest Intl., Inc.

view all

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

Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

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.