Cleared Traditional

VARIANT II TURBO HbA1c Kit - 2.0

K142448 · Bio-Rad Laboratories, Inc. · Chemistry

Mar 2015

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K142448 is an FDA 510(k) clearance for the VARIANT II TURBO HbA1c Kit - 2.0, 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 March 24, 2015, 203 days after receiving the submission on September 2, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K142448 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2014
Decision Date	March 24, 2015
Days to Decision	203 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.