Cleared Traditional

Hipro Glycosylated Hemoglobin (HbA1c) Test System

K220999 · Shijiazhuang Hipro Biotechnology Co., Ltd. · Chemistry

Sep 2024

Decision

892d

Days

Class 2

Risk

About This 510(k) Submission

K220999 is an FDA 510(k) clearance for the Hipro Glycosylated Hemoglobin (HbA1c) Test System, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Shijiazhuang Hipro Biotechnology Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on September 12, 2024, 892 days after receiving the submission on April 4, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K220999 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2022
Decision Date	September 12, 2024
Days to Decision	892 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.