VISION (TM) HDL CHOLESTEROL— 510(k) K871461

Name: FDA 510(k) clearance K871461
Creator: U.S. Food and Drug Administration
Published: 1987-05-14

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K871461 for VISION (TM) HDL CHOLESTEROL, Substantially Equivalent on 1987-05-14. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1987-04-14
Decision date: 1987-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBS

view all

K162593 — HDL-Cholesterol Gen.42016-10-19
K153435 — Direct HDL Cholesterol (HDL)2016-01-08
K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT2014-05-08
K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES2012-09-07
K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER2011-09-27

More clearances from Abbott Laboratories

view all

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

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