510(k) K142448 ยท PDJ Hemoglobin A1c Test System
VARIANT II TURBO HbA1c Kit - 2.0
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Mar 24, 2015 |
| Received | Sep 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142448
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.