510(k) K161687 ยท PDJ Hemoglobin A1c Test System
D-10 Hemoglobin A1c Program
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Oct 14, 2016 |
| Received | Jun 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161687
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.