TQ HBA1C GEN3— 510(k) K102914

Substantially Equivalent

Roche

FDA 510(k) clearance K102914 for TQ HBA1C GEN3, Substantially Equivalent on 2011-01-20. Applicant: Roche. Device class: 2.

Clearance details

Applicant: Roche
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2010-10-01
Decision date: 2011-01-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCP

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 Roche

K113793 — HOMOCYSTEINE TEST2012-06-05

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