K220999
- 510(k) number
- K220999
- Device name
- Hipro Glycosylated Hemoglobin (HbA1c) Test System
- Applicant
- Shijiazhuang Hipro Biotechnology Co., Ltd. CN
- Product code
- PDJ — Hemoglobin A1c Test System
- Decision date
- 2024-09-12
- Date received
- 2022-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K220999.pdf
Official FDA record: K220999
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.