Cleared Traditional

D-100 HbA1c, D-100 HbA1c Calibrator Pack

K151321 · Bio-Rad Laboratories, Inc. · Chemistry

Dec 2015

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K151321 is an FDA 510(k) clearance for the D-100 HbA1c, D-100 HbA1c Calibrator Pack, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on December 9, 2015, 205 days after receiving the submission on May 18, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K151321 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2015
Decision Date	December 09, 2015
Days to Decision	205 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.