510(k) K222439 · LEH Radioimmunoassay, Vancomycin
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 8, 2023 |
| Received | Aug 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222439
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.