Source document or public record
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.
Source
"device_name": "DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
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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