Hipro Glycosylated Hemoglobin (HbA1c) Test System— 510(k) K220999

Name: FDA 510(k) clearance K220999
Creator: U.S. Food and Drug Administration
Published: 2024-09-12

Substantially Equivalent

Shijiazhuang Hipro Biotechnology Co., Ltd.

FDA 510(k) clearance K220999 for Hipro Glycosylated Hemoglobin (HbA1c) Test System, Substantially Equivalent on 2024-09-12. Applicant: Shijiazhuang Hipro Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shijiazhuang Hipro Biotechnology Co., Ltd.
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2022-04-04
Decision date: 2024-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shijiazhuang, CN

Download summary PDF View on FDA.gov ↗

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