ARCHITECT HAVAB-G— 510(k) K113704

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K113704 for ARCHITECT HAVAB-G, Substantially Equivalent on 2012-06-28. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LOL
Device class: Class 2
Regulation: 21 CFR 866.3310
Advisory panel: Microbiology
Date received: 2011-12-16
Decision date: 2012-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOL

K260048 — Elecsys Anti-HAV IgM2026-04-07
K251995 — Access anti-HAV IgM2026-01-27
K243846 — Access anti-HAV2025-09-09
K222850 — HAVAb IgG II2023-08-10
K223403 — LIAISON Anti-HAV; LIAISON XS2022-12-09

More clearances from Abbott Laboratories

K252424 — Anti-HCV Next2026-04-28
K243500 — ARCHITECT iGentamicin2025-07-09
K243168 — Alinity i Rubella IgG2025-06-20
K243283 — Alinity h-series System2025-02-20
K233932 — Alinity i Toxo IgM2024-08-30

Recalls naming K113704

K-number listed on FDA's recall record

Z-1728-2020 — ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.Class II·Terminated·Abbott Gmbh & Co. KG·20200309
Z-0574-2020 — ARCHITECT HAVAB-G Calibrator, REF 6L27-01Class II·Terminated·Abbott Gmbh & Co. KG·20191107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113704.

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