510(k) K260468 ยท PDJ Hemoglobin A1c Test System
H100Plus Hemoglobin Testing System
| Applicant | Shenzhen Lifotronic Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Oct 2, 2026 |
| Received | Feb 12, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260468
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.