510(k) K242294 ยท PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
| Applicant | Diasys Diagnostic Systems GmbH, Holzheim, DE |
| Decision | Substantially Equivalent, May 9, 2025 |
| Received | Aug 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242294
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.