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Hipro Glycosylated Hemoglobin (HbA1c) Test System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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