Cleared Traditional

HbA1c Advanced

K182651 · Beckman Coulter Ireland, Inc. · Chemistry

Jan 2019

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K182651 is an FDA 510(k) clearance for the HbA1c Advanced, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Beckman Coulter Ireland, Inc. (O'Callaghan'S Mills, IE). The FDA issued a Cleared decision on January 16, 2019, 114 days after receiving the submission on September 24, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K182651 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2018
Decision Date	January 16, 2019
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PDJ — Hemoglobin A1c Test System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1373
Definition	Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.