DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls— 510(k) K242294
Substantially EquivalentDiasys Diagnostic Systems GmbH
FDA 510(k) clearance K242294 for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls, Substantially Equivalent on 2025-05-09. Applicant: Diasys Diagnostic Systems GmbH.
Clearance details
- Applicant
- Diasys Diagnostic Systems GmbH
- Product code
- Code PTF
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holzheim, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.