K242294
- 510(k) number
- K242294
- Device name
- DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
- Applicant
- Diasys Diagnostic Systems GmbH DE
- Product code
- PTF — Assay To Measure Pct To Aid In The Risk Assessment O
- Decision date
- 2025-05-09
- Date received
- 2024-08-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242294.pdf
Official FDA record: K242294
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.