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FDA 510(k)

Hipro Glycosylated Hemoglobin (HbA1c) Test System

K-Number: K220999 · 2024-09-12

ApplicantShijiazhuang Hipro Biotechnology Co., Ltd.
Decision Date2024-09-12
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Hipro Glycosylated Hemoglobin (HbA1c) Test System is a medical device manufactured by Shijiazhuang Hipro Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-09-12 under approval number K220999. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hipro Glycosylated Hemoglobin (HbA1c) Test System?

Hipro Glycosylated Hemoglobin (HbA1c) Test System is a medical device that received FDA 510(k) clearance on 2024-09-12. It is manufactured by Shijiazhuang Hipro Biotechnology Co., Ltd.. The 510(k) number is K220999.

When was Hipro Glycosylated Hemoglobin (HbA1c) Test System approved by the FDA?

Hipro Glycosylated Hemoglobin (HbA1c) Test System received FDA 510(k) clearance on 2024-09-12, under approval number K220999.

What company makes Hipro Glycosylated Hemoglobin (HbA1c) Test System?

Hipro Glycosylated Hemoglobin (HbA1c) Test System is manufactured by Shijiazhuang Hipro Biotechnology Co., Ltd..

What is the FDA product code for Hipro Glycosylated Hemoglobin (HbA1c) Test System?

The FDA product code for Hipro Glycosylated Hemoglobin (HbA1c) Test System is PDJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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