510(k) K151321 ยท PDJ Hemoglobin A1c Test System
D-100 HbA1c, D-100 HbA1c Calibrator Pack
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Dec 9, 2015 |
| Received | May 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151321
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.