Cleared Traditional

HEMOGLOBIN A1C REAGENT SET

K051200 · Teco Diagnostics · Toxicology
Aug 2005
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K051200 is an FDA 510(k) clearance for the HEMOGLOBIN A1C REAGENT SET, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on August 8, 2005, 90 days after receiving the submission on May 10, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K051200 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2005
Decision Date August 08, 2005
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

Similar Devices — LCP Assay, Glycosylated Hemoglobin

All 248
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
K221326 · Nova Biomedical Corporation · Nov 2024
Q-Pad Test System
K231465 · Qurasense · Dec 2023
Afinion? HbA1c, Afinion? 2 and Alere Afinion? AS100 Analyzer
K214117 · Abbott Diagnostics Technologies AS · Sep 2023
Aina HbA1c Monitoring System 2
K192987 · Jana Care, Inc. · Mar 2020
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K192369 · Ixensor Co, Ltd. · Oct 2019
OneDraw A1C Test System
K183230 · Drawbridge Health, Inc. · Aug 2019