510(k) K200904 ยท PDJ Hemoglobin A1c Test System
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
| Applicant | Tosoh Bioscience, Inc., South San Franciso CA, US |
| Decision | Substantially Equivalent, Aug 5, 2021 |
| Received | Apr 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200904
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.