510(k) K192199 ยท KPT Calibrator, Dose, Radionuclide
CRC PC Smart Chamber K1
| Applicant | Capintec, Inc., Florham Park NJ, US |
| Decision | Substantially Equivalent, Sep 12, 2019 |
| Received | Aug 13, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192199
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.