SERAQUEST ANTI-SSB— 510(k) K980639

Substantially Equivalent

Quest Intl., Inc.

FDA 510(k) clearance K980639 for SERAQUEST ANTI-SSB, Substantially Equivalent on 1998-06-15. Applicant: Quest Intl., Inc.. Device class: 2.

Clearance details

Applicant: Quest Intl., Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1998-02-19
Decision date: 1998-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLL

K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La2026-08-21
K253367 — EliA CTD 13 Screen2026-06-25
K250666 — Alegria Flash CTD Screen2025-10-22
K250408 — Alegria Flash ENA Screen2025-09-19
K213403 — Aptiva CTD Essential Reagent2023-09-29

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

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