510(k) K162394 ยท KPT Calibrator, Dose, Radionuclide
CRC-77tHR
| Applicant | Capintec, Inc., Florham Park NJ, US |
| Decision | Substantially Equivalent, Mar 8, 2017 |
| Received | Aug 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162394
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.