Cleared Traditional

D-10 Hemoglobin A1c Program

K161687 · Bio-Rad Laboratories, Inc. · Chemistry
Oct 2016
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K161687 is an FDA 510(k) clearance for the D-10 Hemoglobin A1c Program, 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 October 14, 2016, 119 days after receiving the submission on June 17, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number K161687 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2016
Decision Date October 14, 2016
Days to Decision 119 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.

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