510(k) K220999 ยท PDJ Hemoglobin A1c Test System
Hipro Glycosylated Hemoglobin (HbA1c) Test System
| Applicant | Shijiazhuang Hipro Biotechnology Co., Ltd., Shijiazhuang, CN |
| Decision | Substantially Equivalent, Sep 12, 2024 |
| Received | Apr 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220999
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.