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Documento fuente o registro público

FDA 510(k) K242294 — DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k) index record K242294. Device: DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls. Applicant as listed: Diasys Diagnostic Systems GmbH. Decision date: 2025-05-09.

OtherU.S. Food and Drug Administration (FDA)2025-05-09

Fuente

"device_name": "DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-25

Disclaimer

professional use

References

FDA 510(k) public index record K242294.

Device name: DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls. Applicant as listed: Diasys Diagnostic Systems GmbH.

Decision date: 2025-05-09. Decision wording: Substantially Equivalent.

Product code: PTF. Regulation: 21 CFR 866.3215. Medical specialty: Microbiology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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