510(k) K162297 ยท PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Apr 18, 2017 |
| Received | Aug 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162297
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.