ABBOTT IMX GLYCATED HEMOGLOBIN II— 510(k) K992085

Name: FDA 510(k) clearance K992085
Creator: U.S. Food and Drug Administration
Published: 2000-05-25

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K992085 for ABBOTT IMX GLYCATED HEMOGLOBIN II, Substantially Equivalent on 2000-05-25. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1999-06-21
Decision date: 2000-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCP

view all

K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer2024-11-22
K231465 — Q-Pad Test System2023-12-06
K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer2023-09-27
K192987 — Aina HbA1c Monitoring System 22020-03-26
K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit2019-10-29

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.