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Hipro Glycosylated Hemoglobin (HbA1c) Test System

Page Type
Cleared 510(K)
510(k) Number
K220999
510(k) Type
Traditional
Applicant
Shijiazhuang Hipro Biotechnology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/12/2024
Days to Decision
892 days
Submission Type
Summary

Hipro Glycosylated Hemoglobin (HbA1c) Test System

Page Type
Cleared 510(K)
510(k) Number
K220999
510(k) Type
Traditional
Applicant
Shijiazhuang Hipro Biotechnology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/12/2024
Days to Decision
892 days
Submission Type
Summary