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510(k) K220999

Hipro Glycosylated Hemoglobin (HbA1c) Test System by Shijiazhuang Hipro Biotechnology Co., Ltd. — Product Code PDJ

K220999 is an FDA 510(k) premarket notification submitted by Shijiazhuang Hipro Biotechnology Co., Ltd. for the device "Hipro Glycosylated Hemoglobin (HbA1c) Test System". The FDA issued a decision of Substantially Equivalent on September 12, 2024. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2024
Date Received
April 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A1c Test System
Device Class
Class II
Regulation Number
862.1373
Review Panel
CH
Submission Type

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

Other clearances for product code PDJ

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  • K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (October 3, 2025)
  • K242911 — Medconn Glycated Hemoglobin Test system (June 20, 2025)
  • K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (August 5, 2021)
  • K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (July 2, 2021)
  • K193053 — Tina-quant Hemoglobin A1cDx Gen.3 (March 26, 2020)
  • K182651 — HbA1c Advanced (January 16, 2019)
  • K182988 — Afinion HbA1c Dx on Afinion 2 (November 29, 2018)
  • K173909 — Dimension Hemoglobin A1c Assay (July 13, 2018)
  • K173206 — SEKURE HbA1c Assay (July 12, 2018)

FDA data resources