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

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..

Clearance details

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

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